Clinical trial NCT04310748: 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
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Anesthesia
Keywords: Total intravenous anesthesia (TIVA)
inhalation anesthesia
Thiol-disulphide
Oxidative stress
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: TAS (TOTAL ANTIOXIDANE STATUS)
timeFrame: Change from Baseline TAS levels at 2 hours
measure: TOS (TOTAL OXIDANE STATUS)
timeFrame: Change from Baseline TOS levels at 2 hours
measure: Catalase
timeFrame: Change from Baseline Catalase levels at 2 hours
measure: Myeloperoxidase
timeFrame: Change from Baseline Myeloperoxidase levels at 2 hours
measure: Parameters of Thiol- Disulphide Homeostasis
timeFrame: Change from Baseline Thiol- Disulphide levels at 2 hours
Secondary outcomes:
measure: Surgical Satisfaction: score
timeFrame: postoperative 1 minute
measure: Bleeding Scores
timeFrame: postoperative 1 minute
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Bezmialem Vakif University
state: Istanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Kazım Karaaslan, MD
role: STUDY_CHAIR
References: