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

NCT04310748 | Completed

• 1 other identifier: Zeynep01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Anesthesia

Keywords

Total intravenous anesthesia (TIVA); inhalation anesthesia; Thiol-disulphide; Oxidative stress

Outcome Measures

Primary Outcomes (5)

• 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.

  Change from Baseline TAS levels at 2 hours

• 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.

  Change from Baseline TOS levels at 2 hours

• 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.

  Change from Baseline Catalase levels at 2 hours

• 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.

  Change from Baseline Myeloperoxidase levels at 2 hours

• 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.

  Change from Baseline Thiol- Disulphide levels at 2 hours

Secondary Outcomes (2)

• Surgical Satisfaction: score

  postoperative 1 minute

• Bleeding Scores

  postoperative 1 minute

Study Arms (2)

Total Intravenous Anesthesia(TIVA)

ACTIVE COMPARATOR

Anesthesia is maintaining with TIVA (Group 1)

Drug: Total Intravenous Anesthesia(TIVA)

Inhalation Anesthesia

ACTIVE COMPARATOR

Anesthesia is maintaining with inhalation anesthesia (Group 2)

Drug: Inhalation Anesthesia

Interventions

Total Intravenous Anesthesia(TIVA) DRUG

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

Also known as: Group 1

Total Intravenous Anesthesia(TIVA)

Inhalation Anesthesia DRUG

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.

Also known as: Group 2

Inhalation Anesthesia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Inhalation

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• Kazım Karaaslan, MD

  Bezmialem Vakif University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 17, 2020
• Study Start: May 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: January 10, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

TU (1)