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THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients

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ClinicalTrials.gov Identifier: NCT02111265
Recruitment Status : Unknown
Verified April 2014 by Second Affiliated Hospital of Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2014
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by (Responsible Party):
Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary:
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients

Condition or disease Intervention/treatment Phase
Adrenal Suppression Hemodynamic Instability Drug: Remifentanil Drug: Cisatracurium Drug: Sufentanil Device: Bispectral index(BIS) monitor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients ——A Randomized Controlled Trial.
Study Start Date : April 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Drug: Remifentanil
  1. Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia.
  2. Remifentanil is stopped before skin closure
Other Name: Ruijie

Drug: Cisatracurium
  1. Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia.
  2. Cisatracurium is stopped before skin closure.

Drug: Sufentanil
Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.

Device: Bispectral index(BIS) monitor
BiS is maintained at 40-60 during anesthesia.

Experimental: Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Drug: Remifentanil
  1. Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia.
  2. Remifentanil is stopped before skin closure
Other Name: Ruijie

Drug: Cisatracurium
  1. Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia.
  2. Cisatracurium is stopped before skin closure.

Drug: Sufentanil
Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.

Device: Bispectral index(BIS) monitor
BiS is maintained at 40-60 during anesthesia.




Primary Outcome Measures :
  1. Effect Compartment Concentration [ Time Frame: From the beginning of induction to paitens'left of PACU, up to 4 hours ]
    The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake (call then open their eyes).


Secondary Outcome Measures :
  1. vital signs [ Time Frame: From the beginning of induction to skin closure, up to 3 hours ]
    Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation.

  2. The amount of drugs [ Time Frame: From the beginning of induction to skin closure, up to 3 hours ]
    The amount of narcotics, sedation and muscle relaxation used in general anesthesia arr recorded when the operation is finished.

  3. Adrenal function [ Time Frame: From entering the operating room to 48 h after induction of anesthesia. ]
    1. 3 ml blood sample is collected at 5 time points including before induction,30 minutes,2 hours,24 hours, 48 hours after induction;
    2. to examine the concentration of Cortisol, Aldosterone and ACTH in serum:



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
  3. Age 60-75 yrs.
  4. American Society of Anesthesia (ASA) classification I-II.
  5. Expected time of surgery is less than 3 hours. -

Exclusion Criteria:

  1. Body mass index is more than 36kg/m2.
  2. Systolic blood pressure≥180 mm Hg or <90 mm Hg,diastolic blood pressure≥110 mm Hg or < 60 mm Hg.
  3. Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
  4. Long term used hormone or adrenal suppression.
  5. Allergy to trial drug or other contraindication.
  6. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
  7. Abuse of narcotic analgesia or suspected.
  8. Neuromuscular diseases.
  9. Mentally unstable or has a mental illness.
  10. Malignant Hyperthermia.
  11. Pregnant or breast-feeding women.
  12. Attended other trial past 30 days. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111265


Sponsors and Collaborators
Second Affiliated Hospital of Xi'an Jiaotong University
Chinese Medical Association
Investigators
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Principal Investigator: He Jiaxuan Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University

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Responsible Party: Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02111265     History of Changes
Other Study ID Numbers: SAHXJTUA01
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Sufentanil
Remifentanil
Anesthetics
Propofol
Etomidate
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Neuromuscular Blocking Agents
Neuromuscular Agents