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Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia

Primary Purpose

Oxidative Stress, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total Intravenous Anesthesia(TIVA)
Inhalation Anesthesia
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Oxidative Stress focused on measuring Total intravenous anesthesia (TIVA), inhalation anesthesia, Thiol-disulphide, Oxidative stress

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages of 18-55
  • Who will undergo elective rhinoplasty
  • ASA Physical Status Classification System 1

Exclusion Criteria:

  • Patients with a history of smoking,
  • Patients with a history alcohol use
  • Patients with a history drug use,
  • Body Mass Index (BMI)>30
  • Patients with allergies to drugs to be used
  • Patients who refused to participate in the study Termination Criteria
  • Whose blood pressure values are out of the targets determined in 3 consecutive measurements

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Intravenous Anesthesia(TIVA)

Inhalation Anesthesia

Arm Description

Anesthesia is maintaining with TIVA (Group 1)

Anesthesia is maintaining with inhalation anesthesia (Group 2)

Outcomes

Primary Outcome Measures

TAS (TOTAL ANTIOXIDANE STATUS)
Evaluation of the effect of anesthesia technique on oxidative stress by TAS values Plasma TAS levels are measured by a commercial mass developed by Erel. Plasma TAS values are expressed in millimeters with the Trolox value per liter. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
TOS (TOTAL OXIDANE STATUS)
Evaluation of the effect of anesthesia technique on oxidative stress by TOS values 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). 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Catalase
Evaluation of the effect of anesthesia technique on oxidative stress by catalase values The catalase enzyme converts H2O2 into water and oxygen. Catalase enzyme activity decreases in the amount of H2O2 as a result of the dismutase reaction shown by the enzyme in an environment containing H2O2. Catalase enzyme activity is determined by measuring the change in H2O2 concentration at 240 nm. Unit: Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Myeloperoxidase
Evaluation of the effect of anesthesia technique on oxidative stress by Myeloperoxidase values Myeloperoxidase activity is determined by measuring the orange color of o-Dianisidine molecule in oxidized environment with H2O2 at 444 nm colorimetrically. The result is calculated using the molar absorption coefficient of the oxidized o-Dianisidine molecule and defined as Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Parameters of Thiol- Disulphide Homeostasis
Evaluation of the effect of anesthesia technique on oxidative stress by Thiol - Disulphide Homeostasis values Extra reduction of DTNB and further reduction of the disulfide bond produced after the DTNB reaction are prevented. The total thiol content of the sample is measured at 410 nm using the modified Ellman reagent. Native thiol content is subtracted from the total thiol content and half of the difference obtained gives the amount of disulfide bond. Unit: μmol / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.

Secondary Outcome Measures

Surgical Satisfaction: score
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
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,

Full Information

First Posted
March 6, 2020
Last Updated
November 12, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04310748
Brief Title
Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia
Official Title
Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
January 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Total intravenous anesthesia (TIVA) and inhalation anesthesia are two anesthesia methods that can be preferred for the maintenance of anesthesia. Sevoflurane and propofol are drugs used frequently in these methods. This study aims to investigate and compare the effects of inhalation anesthesia using sevoflurane and TIVA using propofol on oxidative stress in patients undergoing controlled hypotensive anesthesia.
Detailed Description
Controlled hypotension is defined as keeping systolic blood pressure in the range of 80-90 mmHg or mean arterial pressure in the range of 50-65 mmHg. Pharmacological and non-pharmacological methods can be used to achieve controlled hypotension. Intravenous anesthetics, inhalation anesthetics, opioids, calcium channel blockers, beta blockers, nitrate derivatives are frequently used drugs for this purpose. General anesthesia maintenance is applied in two ways: total intravenous anesthesia (TIVA) and inhalation anesthesia. The pharmacokinetic and pharmacodynamic properties of drugs used in both methods are quite different. Products of the body's oxidant antioxidant balance can be measured by biochemical methods and information about this balance can be obtained. Thiols are the regions of proteins most susceptible to oxidation, and the conversion of thiols to disulfides and oxyacids is the earliest marker of radical-mediated protein oxidation. 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. In this study, it was aimed to investigate and compare the effects of inhalation anesthesia using sevoflurane and total intravenous anesthesia using propofol on oxidative stress in rhinoplasty cases under controlled hypotension. This assessment was planned using TAS (total antioxidant status), TOS (total oxidant status), Catalase, Myeloperoxidase (MPO), Total Thiol, Native Thiol and Disulfide parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Anesthesia
Keywords
Total intravenous anesthesia (TIVA), inhalation anesthesia, Thiol-disulphide, Oxidative stress

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized controlled prospective study to be performed in 60 patients ASA 1 between the ages of 18-55 who will undergo elective rhinoplasty. History of smoking, alcohol, and drug use, who had a BMI>30 are excluding from the study. BIS and TOF monitoring are performing in all patients undergoing standard anesthesia induction. Patients divided into two groups with closed envelope method; TIVA(Group1) and inhalation anesthesia(Group2). In both, MAP target is determining to be in the range of 50-65 mmHg. Blood sample is collecting and storing to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters, before induction and 5, 30, 60 and 120 minutes after induction. The extubation time is recording. The surgical field opinion and satisfaction assessment and the survey presented to the surgeon, respectively. The patients by following up in the recovery unit for 30 minutes; numerical pain scores and nausea-vomiting scores is recording.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Intravenous Anesthesia(TIVA)
Arm Type
Active Comparator
Arm Description
Anesthesia is maintaining with TIVA (Group 1)
Arm Title
Inhalation Anesthesia
Arm Type
Active Comparator
Arm Description
Anesthesia is maintaining with inhalation anesthesia (Group 2)
Intervention Type
Drug
Intervention Name(s)
Total Intravenous Anesthesia(TIVA)
Other Intervention Name(s)
Group 1
Intervention Description
Ventilation of the patients was provided with a mixture of 40% oxygen and 60% air. Along with induction, propofol at a dose of 6-10 mg/kg/hour and remifentanil infusion at a dose of 0.3-0.4 mcg/kg/min were started for the maintenance of anesthesia. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia. The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. The surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded
Intervention Type
Drug
Intervention Name(s)
Inhalation Anesthesia
Other Intervention Name(s)
Group 2
Intervention Description
Ventilation of the patients was provided with a mixture of 40% oxygen and 60% N2O. As soon as mechanical ventilation started, sevoflurane was opened at a concentration of 2-3% with a MAK value of 1.1-1.3. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia. The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. At the end of the surgery, the surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded.
Primary Outcome Measure Information:
Title
TAS (TOTAL ANTIOXIDANE STATUS)
Description
Evaluation of the effect of anesthesia technique on oxidative stress by TAS values Plasma TAS levels are measured by a commercial mass developed by Erel. Plasma TAS values are expressed in millimeters with the Trolox value per liter. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Time Frame
Change from Baseline TAS levels at 2 hours
Title
TOS (TOTAL OXIDANE STATUS)
Description
Evaluation of the effect of anesthesia technique on oxidative stress by TOS values 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). 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Time Frame
Change from Baseline TOS levels at 2 hours
Title
Catalase
Description
Evaluation of the effect of anesthesia technique on oxidative stress by catalase values The catalase enzyme converts H2O2 into water and oxygen. Catalase enzyme activity decreases in the amount of H2O2 as a result of the dismutase reaction shown by the enzyme in an environment containing H2O2. Catalase enzyme activity is determined by measuring the change in H2O2 concentration at 240 nm. Unit: Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Time Frame
Change from Baseline Catalase levels at 2 hours
Title
Myeloperoxidase
Description
Evaluation of the effect of anesthesia technique on oxidative stress by Myeloperoxidase values Myeloperoxidase activity is determined by measuring the orange color of o-Dianisidine molecule in oxidized environment with H2O2 at 444 nm colorimetrically. The result is calculated using the molar absorption coefficient of the oxidized o-Dianisidine molecule and defined as Unite / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Time Frame
Change from Baseline Myeloperoxidase levels at 2 hours
Title
Parameters of Thiol- Disulphide Homeostasis
Description
Evaluation of the effect of anesthesia technique on oxidative stress by Thiol - Disulphide Homeostasis values Extra reduction of DTNB and further reduction of the disulfide bond produced after the DTNB reaction are prevented. The total thiol content of the sample is measured at 410 nm using the modified Ellman reagent. Native thiol content is subtracted from the total thiol content and half of the difference obtained gives the amount of disulfide bond. Unit: μmol / L. 3 ml of blood was taken from the venous cannula inserted before the induction of anesthesia into MiniCollect® tubes. At 5, 30, 60 and 120 minutes after induction, 3 ml of blood was taken from the drug-free arm.The collected blood was centrifuged at 2000 x g for 10 minutes and the separated serum was stored at -80 ° C until the study was performed.
Time Frame
Change from Baseline Thiol- Disulphide levels at 2 hours
Secondary Outcome Measure Information:
Title
Surgical Satisfaction: score
Description
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
Time Frame
postoperative 1 minute
Title
Bleeding Scores
Description
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,
Time Frame
postoperative 1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages of 18-55 Who will undergo elective rhinoplasty ASA Physical Status Classification System 1 Exclusion Criteria: Patients with a history of smoking, Patients with a history alcohol use Patients with a history drug use, Body Mass Index (BMI)>30 Patients with allergies to drugs to be used Patients who refused to participate in the study Termination Criteria Whose blood pressure values are out of the targets determined in 3 consecutive measurements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazım Karaaslan, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakif University
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

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Effects of TIVA and Inhalation Anesthesia on Oxidative Stress Factors During Hypotensive Anesthesia

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