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Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels

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ClinicalTrials.gov Identifier: NCT04246567
Recruitment Status : Suspended (Ethics approval is expected from the pharmaceutical institution for the study which has received the local ethics committee approval.)
First Posted : January 29, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 29, 2020
Last Update Posted Date May 11, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a [ Time Frame: Change from Baseline HIF 1a 30th minute (t1), 1st hour (t2) and 2st hour (t3) ]
    Under normoxic conditions, HIF 1a protein can hardly be detected, but when hypoxia starts, its expression starts within 2 minutes and peaks at 4-8 hours of hypoxia. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
  • Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TAS [ Time Frame: Change from Baseline TAS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3) ]
    Plasma TAS and TOS levels are measured with a commercial kit developed by Erel. Values for plasma TAS are expressed in millimeters by the Trolox value per liter. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
  • Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS [ Time Frame: Change from Baseline TOS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3) ]
    Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L).5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • surgical satisfaction [ Time Frame: postoperative 1 minute ]
    At the end of the surgery surgeons evaluated surgical satisfaction. the investigators used surgeon satisfaction score which one is performing like that 1- bad 2-moderate 3-good 4-excellent
  • bleeding scores [ Time Frame: postoperative 1 minute ]
    At the end of the surgery surgeons evaluated bleeding scores. the investigators used bleeding score which one is performing like that 0-No bleeding 1-minor bleeding no aspiration required 2- Minor bleeding, aspiration required 3-minor bleeding, frequent aspiration required, 4-Moderate bleeding, visible only with aspiration 5- Severe bleeding, frequent aspiration required and very hard to perform surgery
  • anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram) [ Time Frame: postoperative 1 minute ]
    Standard anesthesia induction and propofol and remifentanil infusion were applied to group 1 patients with TIVA technique. Standard anesthesia induction and 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA were applied to group 2 patients with inhalation anesthesia technique
  • anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml) [ Time Frame: postoperative 1 minute ]
    Standard anesthesia induction and 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA were applied to group 2 patients with inhalation anesthesia technique
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
Official Title  ICMJE Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
Brief Summary The aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia with total intravenous anesthesia or inhalation anesthesia; preoperative and 30. ,60. ,120. second of intraoperative period blood HIF 1a, TAS, TOS measurement and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which hypotensive anesthesia technique is related.
Detailed Description

Controlled hypotension is the voluntary reversible reduction of arterial blood pressure. Hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. İt reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. Hypotensive anesthesia can be performed according to mean blood pressure (MBP) or systolic blood pressure (SBP).

A non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia.

Hypoxia inducible factor (HIF) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia.

The biological activity of HIF 1 is determined by the expression and activity of the HIF 1a subunit.

Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.

Near Infrared Spectroscopy (NIRS) allows continuous and non-invasive monitoring of cerebral oxygenation. HIF 1a, TAS and TOS are laboratory markers that predict tissue oxygenation and perfusion.

Hypotensive anesthesia can be performed according to both MBP and SBP. However, in our study that follow-up MBP is more advantageous/protective, although it is not supported by very strong data. The investigators recommend hypotensive anesthesia compared to MBP; but further studies are needed

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A total of 60 ASA 1 patients aged between 18-55 who underwent elective rhinoplasty surgery were included the study.The patients were divided into two groups. One group received hypotensive anesthesia with total intravenous anesthesia technique according to MBP and the other group received hypotensive anesthesia with inhalation anesthesia technique. Blood samples were taken from all patients before anesthesia induction and 30. ,60. ,120. second of intraoperative period for TAS, TOS, HIF 1a. At the and of the operation patients were fallowed in the post anesthesia care unit for 30 minutes and pain and nause vomiting scores were evaluated. İn addition, surgical satisfaction and bleeding scores and anesthetic consumption of both groups were recorded
Masking: Single (Participant)
Masking Description:
The investigators divided the patients to two groups. Patients were divided into two groups with a lottery. Surgeons did not know which hypotensive anesthesia technique were used. And surgeons evaluated surgical satisfaction and bleeding scores
Primary Purpose: Screening
Condition  ICMJE
  • Hypoxemia During Surgery
  • Hypoxia
Intervention  ICMJE
  • Procedure: Mean Blood Pressure (MBP)
    Mean blood pressure (MBP) for patients 50-65 mmHg
  • Drug: Add to 0.5 mcg / kg fentanyl.
    When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl.
Study Arms  ICMJE
  • Active Comparator: Total intravenous anesthesia technique for group 1 patients

    Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 6-10 mg / kg / h propofol and 0.0,4mcg / kg remifentanyl infusion / min. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.

    Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.

    Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory

    Interventions:
    • Procedure: Mean Blood Pressure (MBP)
    • Drug: Add to 0.5 mcg / kg fentanyl.
  • Active Comparator: Inhalation anesthesia technique for group 2 patients

    Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA to provide a value of BIS between 40-60. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.

    Hemodynamic parameters (HR, SBP, OCD), BIS,TOF and SpO2 were recorded at 5 minute intervals.

    Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory

    Interventions:
    • Procedure: Mean Blood Pressure (MBP)
    • Drug: Add to 0.5 mcg / kg fentanyl.
Publications * Not Provided

*   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 Suspended
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-55 years old
  • ASA Physical Status Classification System 1
  • Undergoing to Elective rhinoplasty

Exclusion Criteria:

  • Patients have any autoimmune disease
  • Smoking of patients
  • Development of any allergic reaction during the procedure
  • Failure to collect blood to be examined at the appropriate time
  • Body mass index is less than 19 or greater than 30

Termination criteria

  • Development of severe hypotension and bradycardia during measurements
  • Development of severe drug allergy during follow-up
  • In the event of any complications related to the surgical procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04246567
Other Study ID Numbers  ICMJE Ayse02
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hayrettin Daşkaya, MD Bezmialem Vakif University
PRS Account Bezmialem Vakif University
Verification Date May 2020

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