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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35816
Enrollment
90
Registered
2011-03-03
Start date
2011-04-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer large bowel cancer

Interventions

Two questionnaires with approximately 15 multiple-choice questions shall be given during this study: the first before randomization and the second after completion of the CT-colonography procedure
Janssen-Cilag, Tilburg, The Netherlands) 7.5 mcg/kg intravenously through the cannula. The participants from group 2 will receive a placebo, in this study a 0.9% saline solution. This placebo is cho

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Hypotension (systolic blood pressure 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

Design outcomes

Primary

MeasureTime frame
The difference between the alfentanil group and placebo group in maximum pain score during insufflation.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)