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

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ClinicalTrials.gov Identifier: NCT00446420
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Drug: Propofol, midazolam, fentanyl Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Study Start Date : February 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: 1
These patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs
Drug: Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Other Names:
  • Diprivan
  • Sublimase
  • Versed

Active Comparator: 2
These patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.
Drug: Propofol, midazolam, fentanyl
All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
Other Names:
  • Diprivan
  • Sublimase
  • Versed




Primary Outcome Measures :
  1. Cognitive impairment at hospital discharge after elective outpatient colonoscopy [ Time Frame: Before discharge from daycare facility ]

Secondary Outcome Measures :
  1. Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care [ Time Frame: Before discharge from daycare facility ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446420


Locations
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00446420     History of Changes
Other Study ID Numbers: 2006.228
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Propofol
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action