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Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery

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ClinicalTrials.gov Identifier: NCT03917004
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Liang Bing, Guangzhou Red Cross Hospital

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • cardiac index(CI) after the participants are taken into the operating room [ Time Frame: during surgery ]
    CI(L/min/m^2)
  • cardiac index(CI) after the induction [ Time Frame: during surgery ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    cardiac index (CI,L/min/m^2).
  • cardiac index(CI) at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at the end of surgery [ Time Frame: at the end of surgery ]
    cardiac index (CI,L/min/m^2).
  • cardiac index(CI) at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    cardiac index (CI,L/min/m^2)
  • cardiac index(CI) at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    cardiac index (CI,L/min/m^2)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Partial pressure of oxygen after the participants are taken into the operating room [ Time Frame: during surgery ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation after the participants are taken into the operating room [ Time Frame: during surgery ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin after the participants are taken into the operating room [ Time Frame: during surgery ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate after the participants are taken into the operating room [ Time Frame: during surgery ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen after the participants are taken into the operating room [ Time Frame: during surgery ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation after the participants are taken into the operating room [ Time Frame: during surgery ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index after the participants are taken into the operating room [ Time Frame: during surgery ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index after the participants are taken into the operating room [ Time Frame: during surgery ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen after the induction [ Time Frame: during surgery ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation after the induction [ Time Frame: during surgery ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin after the induction [ Time Frame: during surgery ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate after the induction [ Time Frame: during surgery ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen after the induction [ Time Frame: during surgery ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation after the induction [ Time Frame: during surgery ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index after the induction [ Time Frame: during surgery ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index after the induction [ Time Frame: during surgery ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Calculated index at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Partial pressure central venous oxygen at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Arterial blood lactate at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Oxygen supply index at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Central venous blood oxygen saturation at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Partial pressure of oxygen at the end of surgery [ Time Frame: at the end of surgery ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at the end of surgery [ Time Frame: at the end of surgery ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at the end of surgery [ Time Frame: at the end of surgery ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at the end of surgery [ Time Frame: at the end of surgery ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at the end of surgery [ Time Frame: at the end of surgery ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at the end of surgery [ Time Frame: at the end of surgery ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at the end of surgery [ Time Frame: at the end of surgery ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at the end of surgery [ Time Frame: at the end of surgery ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Partial pressure of oxygen at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Partial pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Partial pressure central venous oxygen(PvO2,mmHg)
  • Central venous blood oxygen saturation at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Oxygen consumption index (VO2I,ml/min/m^2)
  • Plartia pressure of oxygen at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Plartia pressure of oxygen (PaO2,mmHg)
  • Arterial oxygen saturation at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Arterial oxygen saturation (SaO2,%)
  • Arterial blood hemoglobin at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Arterial blood hemoglobin (Hb,g/L)
  • Arterial blood lactate at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Arterial blood lactate (Lac,mmol/L)
  • Partial pressure central venous oxygen at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Partial pressure central venous oxnyge(PvO2,mmHg)
  • Central venous blood oxygen saturation at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Central venous blood oxygen saturation(ScvO2,%)
  • Oxygen supply index at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Oxygen supply index (DO2I,ml/min/m^2)
  • Oxygen consumption index at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Oxygen consumption index (VO2I,ml/min/m^2).
  • mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room [ Time Frame: during surgery ]
    MAP(mmHg)
  • heart rate(HR) after the participants are taken into the operating room [ Time Frame: during surgery ]
    HR(beat per minute)
  • central venous pressure(CVP) after the participants are taken into the operating room [ Time Frame: during surgery ]
    CVP(mmHg)
  • variability of stroke volume(SVV) after the participants are taken into the operating room [ Time Frame: during surgery ]
    SVV (%)
  • mean artery pressure(MAP) after the induction [ Time Frame: during surgery ]
    MAP(mmHg)
  • heart rate(HR) after the induction [ Time Frame: during surgery ]
    HR(heart rate,beat per minute)
  • central venous pressure(CVP) after the induction [ Time Frame: during surgery ]
    CVP(mmHg)
  • variability of stroke volume(SVV) after the induction [ Time Frame: during surgery ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    MAP(mmHg)m^2)
  • heart rate(HR) at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    HR(heart rate,beat per minute),
  • central venous pressure(CVP) at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    MAP(mmHg)
  • heart rate(HR) at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    HR(heart rate,beat per minute)
  • central venous pressure(CVP) at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    MAP(mmHg)
  • heart rate(HR) at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    HR(heart rate,beat per minute)
  • central venous pressure(CVP) at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    MAP(mmHg)
  • heart rate(HR) at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    HR(heart rate,beat per minute)
  • central venous pressure(CVP) at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    MAP(mmHg)
  • heart rate(HR) at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    HR(heart rate,beat per minute)
  • central venous pressure(CVP) at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    SVV (variability of stroke volume,%)
  • mean artery pressure(MAP) at the end of surgery [ Time Frame: at the end of surgery ]
    MAP(mmHg)
  • central venous pressure(CVP) at the end of surgery [ Time Frame: at the end of surgery ]
    CVP(mmHg)
  • variability of stroke volume(SVV) at the end of surgery [ Time Frame: at the end of surgery ]
    SVV (variability of stroke volume,%)
  • heart rate(HR) at the end of surgery [ Time Frame: at the end of surgery ]
    HR(heart rate,beat per minute)
  • mean artery pressure(MAP) at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    MAP(mmHg)
  • heart rate(HR) at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    HR(heart rate,beat per minute)
  • variability of stroke volume(SVV) at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    SVV (variability of stroke volume,%)
  • central venous pressure(CVP) at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    CVP(mmHg)
  • mean artery pressure(MAP) at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    MAP(mmHg)
  • central venous pressure(CVP) at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    CVP(mmHg)
  • heart rate(HR) at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    HR(heart rate,beat per minute)
  • variability of stroke volume(SVV) at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    SVV (variability of stroke volume,%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2019)
  • Scores of surgical field quality after the induction [ Time Frame: during surgery ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at the end of surgery [ Time Frame: at the end of surgery ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • Scores of surgical field quality at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
  • operation time after the induction [ Time Frame: during surgery ]
    operation time(minutes)
  • operation time after the participants are taken into the operating room [ Time Frame: during surgery ]
    operation time(minutes)
  • operation time at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    operation time(minutes)
  • operation time at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    operation time(minutes)
  • operation time at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    operation time(minutes)
  • operation time at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    operation time(minutes)
  • operation time at 45 minutes after tubation [ Time Frame: 45 minutes after tubation ]
    operation time(minutes)
  • operation time at the end of surgery [ Time Frame: at the end of surgery ]
    operation time(minutes)
  • operation time at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    operation time(minutes)
  • operation time at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    operation time(mintes)
  • estimated blood loss after the induction [ Time Frame: during surgery ]
    estimated blood loss(ml)
  • estimated blood loss after the participants are taken into the operating room [ Time Frame: during surgery ]
    estimated blood loss(ml)
  • estimated blood loss at 5 minutes after tubation [ Time Frame: 5 minutes after tubation ]
    estimated blood loss(ml)
  • estimated blood loss at 10 minutes after tubation [ Time Frame: 10 minutes after tubation ]
    estimated blood loss(ml)
  • estimated blood loss at 15 minutes after tubation [ Time Frame: 15 minutes after tubation ]
    estimated blood loss(ml)
  • estimated blood loss at 30 minutes after tubation [ Time Frame: 30 minutes after tubation ]
    estimated blood loss(ml)
  • estimated blood loss at 45minutes after tubation [ Time Frame: 45 minutes after tubation ]
    estimated blood loss(ml)
  • estimated blood loss at the end of surgery [ Time Frame: at the end of surgery ]
    estimated blood loss(ml)
  • estimated blood loss at 1 minute after extubation [ Time Frame: 1 minute after extubation ]
    estimated blood loss(ml)
  • estimated blood loss at 5 minutes after extubation [ Time Frame: 5 minutes after extubation ]
    estimated blood loss(ml)
  • Scores of surgical field quality after the participants are taken into the operating room [ Time Frame: during surgery ]
    Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery
Official Title  ICMJE Correlation Analysis of the Effects of Management Pressure Goals (Controlled Hypotension) and Control Volume Goals (Cardiac Output, Stroke Volume Variability, Central Venous Pressure) on Intraoperative Blood and Visual Field Quality
Brief Summary The investigators study 160 patients undergoing spinal surgery.Participants will be randomly divided into study group and control group.The study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to CI.
Detailed Description

This study will be done in Guangzhou Red Cross Hospital .The investigators study 160 patients aged from 45 to 70 years,weight from 48 to 68kg classified as American Society of Anesthesiologists (ASAs) physical status Ⅰ-Ⅱ who will be candidate for posterior decompression of vertebral canal,discectomy and internal fixation by pediclescrew(one centrum).The investigators excluded patients with cardiovascular and cerebrovascular diseases,hepatic or renal dysfunction,and patients receiving drugs that interfere with coagulation before surgery.

Patients randomly divided into study group(group H,n=120)and control group (group C,n=40).The study group according to CI(Cardiac Index) levels of intraoperative hypotension period(mean of CI at T2,T3,T4) were divided into three groups: 1st group: CI: 1.5-2.0 L /(min•m2), 2nd group: CI: 2.0-3.0 L /(min•m2), 3rd group: CI: 3.0-4.0 L /(min•m2),and which CI < 1.5 or CI > 4.0 was eliminated the experimental group, which, in control group, CI< 2.5 or CI >4.0 was eliminated the experimental group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypotension,Controlled
Intervention  ICMJE Drug: Nitroglycerin
The starting rate of "nitroglycerin" was 0.25 μg / kg / min and the mean arterial pressure (MAP) decreased to 80% of the baseline but not less than 70%.The drug infusion rate was adjusted so that the MAP was maintained in the range to the suture, and the administration was stopped and the blood pressure was gradually returned to the pre-depressurization level.
Other Name: Controlled Hypotension
Study Arms  ICMJE
  • Experimental: hypotension group (group H )
    particcipants in hypotension group are received controlled hypertension in the operation.
    Intervention: Drug: Nitroglycerin
  • No Intervention: control group (group C )
    participants in cotrol group are received no controlled hypertension in the operation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged between 35 and 70 years
  2. Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body)

Exclusion Criteria:

  1. History of cardiovascular function

    1. congestive heart failure [CHF]
    2. coronary artery disease [CAD]
    3. cerebrovascular insuffiency)
  2. poorly controlled arterial hypertension
  3. pre-existing coagulation defects
  4. Patients taking anticoagulatory medication including aspirin
  5. Patients taking corticosteroid therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cao Yang +86-020-34403854 caoy2008@163.com
Contact: Yang
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917004
Other Study ID Numbers  ICMJE 2018-032-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Liang Bing, Guangzhou Red Cross Hospital
Study Sponsor  ICMJE Liang Bing
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cao Yang Guangzhou Red Cross Hospital
PRS Account Guangzhou Red Cross Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP