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 endoscopists 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
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