A randomized double-blind placebo controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT-colonography

Completed

• Conditions: colorectal cancer; large bowel cancer; 10017934; 10017991

• Registration Number: NL-OMON35816
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

18 tot 85 years
Written informed consent
Scheduled for CT-colonography for symptoms or increased risk for colorectal cancer (including patients referred after incomplete colonoscopy)

Exclusion Criteria

Hypotension (systolic blood pressure <90mmHg)
Bradycardia (heart rate < 50 bpm)
Severe COPD
Known allergy for alfentanil
Pregnancy
Severe liver disease (defined as a Child-Pugh score >4)
Use of MAO-inhibitors or within two weeks before the CT-colonography procedure
Use of barbiturates, opiates or daily benzodiazepine use
Known increased intracranial pressure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference between the alfentanil group and placebo group in maximum pain<br /><br>score during insufflation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in:<br /><br>*Pain score in all insufflation positions (left and right decubitus, supine and<br /><br>prone) and the average pain score<br /><br>*Pain and burden of all CT-colonography aspects (telebrix, cannula insertion,<br /><br>insufflation) and total pain and burden of CT-colonography<br /><br>*Side-effects of alfentanil during CT-colonography including:<br /><br>- respiratory effects (apnoea, respiratory frequency and blood oxygenation)<br /><br>- hemodynamics (heart rate and blood pressure)<br /><br>*Procedure and recovery time<br /><br>*The most painful and most burdenful aspect of CT-colonography </p><br>