NCT03417518

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

January 25, 2018

Last Update Submit

February 8, 2018

Conditions

AnesthesiaObesity

Keywords

Oxidative stressBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • C-Reactive Protein (CRP) in blood sample

    up to 24 hours post bariatric surgery

  • Monocyte level in blood sample

    up to 24 hours post bariatric surgery

  • Pain assessed by Visual Analog Scale (VAS)

    up to 48 hours after surgery

  • Side-effects (nausea, vomiting, somnolence, respiratory depression)

    up to 48 hours after surgery

Study Arms (2)

Desflurane Inhalant Product Group

ACTIVE COMPARATOR

general anesthesia with desflurane

Drug: Desflurane Inhalant Product

Propofol Group

EXPERIMENTAL

general anesthesia with propofol

Drug: Propofol

Interventions

Desflurane Inhalant ProductDRUG

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

Also known as: Suprane
Desflurane Inhalant Product Group
PropofolDRUG

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

Also known as: Diprivan
Propofol Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergic to anesthesia agent
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 18298345BACKGROUND

  • 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.

    PMID: 16054557BACKGROUND

  • 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.

    PMID: 1319189BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

DesfluranePropofol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Panayota Kapessidou

    University Hospital Saint-Pierre (CHU Saint-Pierre), Universite libre de Bruxelles (ULB)

    STUDY DIRECTOR

  • Livia Di Marco, doctor

    University Hospital Saint-Pierre (CHU Saint-Pierre)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

January 31, 2018

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

September 1, 2016

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share