Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417518
• Other study ID #: B076201420067
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2018
• Last updated: February 8, 2018
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Obesity

Intervention

Drug:
• Desflurane Inhalant Product
General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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