Does a propofol or sevoflurane based protocol has an effect on bowel motility during laparosopic surgery.
| ISRCTN | ISRCTN12921661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12921661 |
| Secondary identifying numbers | AZG 2013017 |
- Submission date
- 03/07/2015
- Registration date
- 19/08/2015
- Last edited
- 26/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Loofstraat 43
Kortrijk
8500
Belgium
Study information
| Study design | Single-centre prospective randomized controlled single-blind two-arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of propofol and sevofurane on intestinal motility during laparoscopic surgery: a single blind randomized controlled trial. |
| Study objectives | Propofol anaesthesia increases intestinal motility during laparoscopic gastric bypass surgery compared to sevoflurane based anaesthesia. |
| Ethics approval(s) | AZ Groeninge Ethical Committee, 04/03/2013, ref: 13006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 1. Propofol 2. Sevoflurane |
| Primary outcome measure | Intestinal motility measured by visual count of peristaltic waves |
| Secondary outcome measures | N/A |
| Overall study start date | 01/10/2012 |
| Completion date | 01/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25/group |
| Key inclusion criteria | All patients presenting for laparoscopic Roux en Y bariatric surgery at AZ Groeninge Hospital |
| Key exclusion criteria | Redo surgery |
| Date of first enrolment | 01/04/2013 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Belgium
Study participating centre
8500 Kortrijk
Kortrijk
8500
Belgium
Sponsor information
Hospital/treatment centre
Loofstraat 43
Kortrijk
8500
Belgium
"ROR" |
https://ror.org/01cz3wf89 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in Peer reviewed Anaesthesia Journal (eg. Acta Anaesthesiologica Scandinavica) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No |
Editorial Notes
26/01/2016: Publication reference added.
