Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Anesthesia
• Intervention / Treatment: Drug: Desflurane Inhalant Product; Drug: Propofol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Desflurane Inhalant Product Group; general anesthesia with desflurane	Drug: Desflurane Inhalant Product; General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane; Other Names: Suprane
EXPERIMENTAL: Propofol Group; general anesthesia with propofol	Drug: Propofol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde (MDA) level in blood sample	Plasma MDA level is measured as an oxidative stress marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.	up to 24 hours post bariatric surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-Reactive Protein (CRP) in blood sample	Plasma CRP level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.	up to 24 hours post bariatric surgery
Monocyte level in blood sample	Monocyte level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.	up to 24 hours post bariatric surgery
Pain assessed by Visual Analog Scale (VAS)	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)	up to 48 hours after surgery
Side-effects (nausea, vomiting, somnolence, respiratory depression)	Evaluation at 2 hours, 24 hours and 48 hours post-surgical incision	up to 48 hours after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Study Director: Panayota Kapessidou, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB); Principal Investigator: Livia Di Marco, doctor, University Hospital Saint-Pierre (CHU Saint-Pierre)

Publications and helpful links

General Publications

• Skalicky J, Muzakova V, Kandar R, Meloun M, Rousar T, Palicka V. Evaluation of oxidative stress and inflammation in obese adults with metabolic syndrome. Clin Chem Lab Med. 2008;46(4):499-505. doi: 10.1515/CCLM.2008.096.
• Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
• Murphy PG, Myers DS, Davies MJ, Webster NR, Jones JG. The antioxidant potential of propofol (2,6-diisopropylphenol). Br J Anaesth. 1992 Jun;68(6):613-8. doi: 10.1093/bja/68.6.613.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Oxidative stress; Bariatric surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane
• Other Study ID Numbers: B076201420067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No