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NCT Number: NCT03417518

Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients

Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.

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Key information

Conditions

Anesthesia Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) >35
  • scheduled gastric by pass surgery
  • American Society of Anesthesiologists (ASA) <III

Exclusion criteria

  • Allergic to anesthesia agent
  • patient refusal

Treatment and study plan

Desflurane Inhalant Product

Drug

General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane

Other names: Suprane

Propofol

Drug

General anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode

Other names: Diprivan

Primary outcomes

  1. Malondialdehyde (MDA) level in blood sample

    Time frame: up to 24 hours post bariatric surgery

    Plasma MDA level is measured as an oxidative stress marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.

Secondary outcomes

  1. C-Reactive Protein (CRP) in blood sample

    Time frame: up to 24 hours post bariatric surgery

    Plasma CRP level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.

  2. Monocyte level in blood sample

    Time frame: up to 24 hours post bariatric surgery

    Monocyte level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.

  3. Pain assessed by Visual Analog Scale (VAS)

    Time frame: up to 48 hours after surgery

    Pain level is determined at 2 hours, 24 hours and 48 hours post-surgical incision. Visual analog pain score (scale = 0 no pain; 10= worst pain imaginable)

  4. Side-effects (nausea, vomiting, somnolence, respiratory depression)

    Time frame: up to 48 hours after surgery

    Evaluation at 2 hours, 24 hours and 48 hours post-surgical incision

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study title

Effects of General Anesthesia With Propofol Versus Desflurane on Oxidative Stress and Inflammation in Obese Patients Scheduled for Bariatric Surgery

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 31, 2018
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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