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OpenTrials
Completed

NCT Number: NCT00446420

Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations

Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.

200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

About this study

A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation

Exclusion criteria

  • No cognitive impairment
  • Adequate English language comprehension
  • Not combined with other procedures

Treatment and study plan

Propofol, midazolam, fentanyl

Drug

All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy

Other names: Diprivan, Sublimase, Versed

Primary outcomes

  1. Cognitive impairment at hospital discharge after elective outpatient colonoscopy

    Time frame: Before discharge from daycare facility

Secondary outcomes

  1. Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care

    Time frame: Before discharge from daycare facility

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2007
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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