Condition category
Surgery
Date applied
03/07/2015
Date assigned
19/08/2015
Last edited
26/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
During laparoscopic surgery, small bowel paralysis facilitates surgical conditions. This is especially important when complex surgery, with intestinal suturing or stapling, is performed. Both opioids and hypnotic agents might influence small bowel peristalsis. The effects of opioids on intestinal motility (intestinal contractions) are well studied and are known to result in intestinal paralysis. With reference to the effects of hypnotics on intestinal motility, data are scarce. Our group recently studied the effect of different volatile (inhaled) anaesthetics on intestinal motility during laparoscopic surgery requiring small bowel anastomosis (removal of a piece of bowel followed by the joining up of the remaining sections). There were statistically significant less peristaltic waves (involuntary muscle movements in the bowel) in the sevoflurane-based anaesthesia group compared to the desflurane-based anaesthesia group. Stimulation of the irritant Transient Receptor Potential channel A1 (TRPA1) was offered to explain the increased intestinal motility observed with desflurane compared to sevoflurane. Given the fact that propofol is a direct modulator of TRPA1, we hypothesized that propofol increases intestinal motility during anaesthesia compared to sevoflurane.

Who can participate?
All patients presenting for gastric bypass surgery at the AZ Groeninge Hospital

What does the study involve?
Patients are randomized in two study groups. One group receives a propofol based anesthesia and one group receives a sevoflurane based anesthesia. At a specific time point during surgery, intestinal motility is assessed by the surgeon and scrub nurse.

What are the possible benefits and risks of participating?
Benefits include an advancement in better understanding of the effects of anesthetics on intestinal motility. No risks are involved in participating in the study, besides the risk involved with anesthesia and surgery.

Where is the study run from?
AZ Groeninge Hospital, Kortrijk (Belgium)

When is the study starting and how long is it expected to run for?
April 2013 to December 2013

Who is funding the study?
AZ Groeninge Hospital (Belgium)

Who is the main contact?
Matthias Desmet

Trial website

Contact information

Type

Public

Primary contact

Dr Matthias Desmet

ORCID ID

Contact details

Loofstraat 43
Kortrijk
8500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AZG 2013017

Study information

Scientific title

The effect of propofol and sevofurane on intestinal motility during laparoscopic surgery: a single blind randomized controlled trial.

Acronym

Study hypothesis

Propofol anaesthesia increases intestinal motility during laparoscopic gastric bypass surgery compared to sevoflurane based anaesthesia.

Ethics approval

AZ Groeninge Ethical Committee, 04/03/2013, ref: 13006

Study design

Single-centre prospective randomized controlled single-blind two-arm interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Observation of intestinal motility during laparoscopic surgery

Intervention

2-arm study:
1. Group TIVA (Total Intravenous Anesthesia) will receive a propofol based anesthesia
2. Group Sevo will receive a sevoflurane based anesthesia

Intervention type

Drug

Phase

Phase IV

Drug names

1. Propofol
2. Sevoflurane

Primary outcome measures

Intestinal motility measured by visual count of peristaltic waves

Secondary outcome measures

N/A

Overall trial start date

01/10/2012

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All patients presenting for laparoscopic Roux en Y bariatric surgery at AZ Groeninge Hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25/group

Participant exclusion criteria

Redo surgery

Recruitment start date

01/04/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Belgium

Trial participating centre

AZ Groeninge
Loofstraat 43 8500 Kortrijk
Kortrijk
8500
Belgium

Sponsor information

Organisation

Dpt Anesthesia, AZ Groeninge

Sponsor details

Loofstraat 43
Kortrijk
8500
Belgium

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Anesthesia, AZ Groeninge Hospital (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in Peer reviewed Anaesthesia Journal (eg. Acta Anaesthesiologica Scandinavica)

Intention to publish date

01/09/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26806956

Publication citations

Additional files

Editorial Notes

26/01/2016: Publication reference added.