Deep sedation compared with moderate sedation in polyp detection during colonoscopy
| ISRCTN | ISRCTN88128756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88128756 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/07/2010
- Registration date
- 26/08/2010
- Last edited
- 26/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gregorios Paspatis
Scientific
Scientific
Knossou Avenue
Heraklion
71409
Greece
| paspati@admin.teiher.gr |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Deep sedation compared with moderate sedation in polyp detection during colonoscopy: a randomised controlled trial |
| Study objectives | We sought to compare the performance of colonoscopy for the detection of polyps in patients sedated with deep sedation and moderate sedation. |
| Ethics approval(s) | Venizelion Ethics Committee approved on the 4th March 2010 (ref: 2517) |
| Health condition(s) or problem(s) studied | Sedation/colonoscopy |
| Intervention | Patients in both groups initially received intravenously (IV) 2 mg (less than 70 kg body weight [b.w.]) or 3 mg (greater than 70 kg b.w.) of midazolam and 25 mg of pethidine. Additional midazolam was carefully titrated in boluses of 1 mg IV to achieve the desired level of sedation, moderate or deep according to the randomisation. Bolus doses of 25 mg pethidine were also given if patients complained of pain or if there were other indications of pain such as facial grimaces, movement and a sudden increase in heart rate. All colonoscopies were performed with wide-angle (170°), high-resolution videocolonoscopes: 1. Olympus (CFH180AL, Tokyo, Japan) with a high-definition 1080-line screen 2. Olympus (OEV191H, Tokyo, Japan) and video processor Olympus (EVIS EXERA II CV-180, Tokyo, Japan) Patients were treated with sedatives during the procedure (colonoscopy), which lasted from 15 to 45 min approximately for every patient. There wasn't follow up for any arm of our trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Polyp detection rate, measured at end of study |
| Secondary outcome measures | Measured at end of study: 1. Patients' and the endoscopists satisfaction 2. Recovery time 3. Adverse events related to sedation |
| Overall study start date | 06/06/2009 |
| Completion date | 15/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 504 |
| Key inclusion criteria | 1. Patients aged 50 years and older, either sex 2. Undergoing colonoscopy for colorectal cancer (CRC) screening, postpolypectomy surveillance, or other indications for which the primary goal of the examination was detection of neoplasia |
| Key exclusion criteria | 1. Polyposis syndromes 2. Hereditary nonpolyposis CRC 3. Previous surgical resection of the colon or rectum 4. Active anticoagulation 5. Inflammatory bowel disease 6. Cases with inadequate bowel preparation 7. Incomplete colonoscopy 8. Cases where the desired level of sedation was not achieved or the level of unintended level of deep sedation occurred |
| Date of first enrolment | 06/06/2009 |
| Date of final enrolment | 15/10/2009 |
Locations
Countries of recruitment
- Greece
Study participating centre
Knossou Avenue
Heraklion
71409
Greece
71409
Greece
Sponsor information
Venizelion General Hospital of Heraklion (Greece)
Hospital/treatment centre
Hospital/treatment centre
Knossou Avenue
Heraklion
71409
Greece
| iatrikiyp@venizeleio.gr | |
| Website | http://www.venizeleio.gr/ |
"ROR" |
https://ror.org/043889z90 |
Funders
Funder type
Hospital/treatment centre
Venizelion General Hospital of Heraklion (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
