Clinical trial NCT03814577: A Comparison of the Effects of Desflurane and TIVA on Antioxidant System in Morbidly Obese Patients
Official title: A Comparison of the Effects of Desflurane and Total Intravenous Anesthesia (TIVA) on Antioxidant System in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Morbid Obesity
Keywords: General anesthesia
Inhalation anesthetics
Total Intravenous anesthesia
Oxidative Stress
Morbid Obesity
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Clinical Study
Primary purpose: SCREENING

Brief summary: With the development of technology, the safety of anesthesia devices and the progression of monitoring techniques affect the anesthetic management. There are some disadvantages such as high cost of inhalation anesthetics and long postoperative recovery time. The effects of total intravenous anesthesia (TIVA), which has been used for many years and whose positive aspects are well known, on antioxidant system in high risk patients such as morbid obese should be investigated. The aim of this study was to compare the effects of desflurane anesthesia and total intravenous anesthesia (TIVA) on the antioxidant system in morbidly obese patients undergoing bariatric surgery.

Detailed description: Obesity is a chronic disease that negatively affects the quality and duration of life. It is one of the most important health problem in the world and very common in Turkey. Morbid obesity operations have started to be performed frequently in our country with the effective results obtained with the continuation of weight loss after being widely applied in Europe and the United States. In our country, with the increase of obesity, laparoscopic bariatric is preferred especially with low complication rates.

Inhalation anesthesia is still a major source of chemical hazard in the hospital environment due to the widespread use in operating rooms. Factors affecting the presence of anesthetic gases in the environment; device leakage, ventilation, fresh gas flow and operation of the air wasting system. Long-term exposure to anesthetic gases is known to adversely affect the health of the workers in the operating room.

It has been shown that many anesthetic agents produce free radicals and alter serum antioxidant levels in patients. Antioxidant enzymes clean free radicals. Free radicals induced by various diseases can trigger oxidative stress and result in increased oxidative products. It was reported that particularly desflurane induced oxidative stress and increased oxidative products. At the same time, it was reported that desflurane triggered local and systemic oxidative stress in the experimental studies, but propofol had antioxidant properties.

With the development of technology, the safety of anesthesia devices and the progression of monitoring techniques affect the anesthetic management. There are some disadvantages such as high cost of inhalation anesthetics and long postoperative recovery time. The effects of total intravenous anesthesia (TIVA), which has been used for many years and whose positive aspects are well known, on antioxidant system in high risk patients such as morbid obese should be investigated. The aim of this study was to compare the effects of desflurane anesthesia and total intravenous anesthesia (TIVA) on the antioxidant system in morbidly obese patients undergoing bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology score I-III,
* 18-65 years,
* BMI\> 40

Exclusion Criteria:

* American Society of Anesthesiology IV,
* Under 18 years,
* Over 65 years,
* Obstetric patients,
* Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease,
* Cerebrovascular disease,
* Patients who refused informed consent forms

Primary outcomes:
measure: Total Antioxidant Status
timeFrame: Total Antioxidant Status 15 minutes before the anesthesia (preoperative period)
measure: Total Antioxidant Status
timeFrame: Total Antioxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction)
measure: Total Antioxidant Status
timeFrame: Total Antioxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery)
measure: Total Oxidant Status
timeFrame: 120 minutes
measure: Total Oxidant Status
timeFrame: Total Oxidant Status during the anesthesia (perioperative period, 60 minutes after the anesthesia induction)
measure: Total Oxidant Status
timeFrame: Total Oxidant Status after the anesthesia (postoperative period, 120 minutes after the surgery)
Secondary outcomes:
measure: Heart rate
timeFrame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours]
measure: Mean Arterial Pressure
timeFrame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Sedat Akbas
state: Türkiye-Türkçe
Study officials:
affiliation: Inonu University Medical Faculty
name: Sedat Akbas, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han C, Ding W, Jiang W, Chen YU, Hang D, Gu D, Jiang G, Tan Y, Ge Z, Ma T. A comparison of the effects of midazolam, propofol and dexmedetomidine on the antioxidant system: A randomized trial. Exp Ther Med. 2015 Jun;9(6):2293-2298. doi: 10.3892/etm.2015.2410. Epub 2015 Apr 7.