Condition category
Surgery
Date applied
26/07/2010
Date assigned
26/08/2010
Last edited
26/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gregorios Paspatis

ORCID ID

Contact details

Knossou Avenue
Heraklion
71409
Greece
paspati@admin.teiher.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Deep sedation compared with moderate sedation in polyp detection during colonoscopy: a randomised controlled trial

Acronym

Study hypothesis

We sought to compare the performance of colonoscopy for the detection of polyps in patients sedated with deep sedation and moderate sedation.

Ethics approval

Venizelion Ethics Committee approved on the 4th March 2010 (ref: 2517)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Polyp detection rate, measured at end of study

Secondary outcome measures

Measured at end of study:
1. Patients' and the endoscopist’s satisfaction
2. Recovery time
3. Adverse events related to sedation

Overall trial start date

06/06/2009

Overall trial end date

15/10/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

504

Participant 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

Recruitment start date

06/06/2009

Recruitment end date

15/10/2009

Locations

Countries of recruitment

Greece

Trial participating centre

Knossou Avenue
Heraklion
71409
Greece

Sponsor information

Organisation

Venizelion General Hospital of Heraklion (Greece)

Sponsor details

Knossou Avenue
Heraklion
71409
Greece
iatrikiyp@venizeleio.gr

Sponsor type

Hospital/treatment centre

Website

http://www.venizeleio.gr/

Funders

Funder type

Hospital/treatment centre

Funder name

Venizelion General Hospital of Heraklion (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes