The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
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|ClinicalTrials.gov Identifier: NCT00376831|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : August 10, 2007
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.
There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.
This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.
The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.
The results will be compiled from objective data and patient and physician interviews.
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy Conscious Sedation||Drug: Midazolam, Fentanyl Drug: KETAMINE, MIDAZOLAM||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||June 2007|
Active Comparator: 0
Drug: Midazolam, Fentanyl
fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
Active Comparator: 1
Drug: KETAMINE, MIDAZOLAM
Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
- Recovery time [ Time Frame: 24 hours following colonoscopy ]
- Sedative effect [ Time Frame: 24 hours following colonoscopy ]
- Patient compliance [ Time Frame: 24 hours following colonoscopy ]
- Side effects [ Time Frame: 24 hours following colonoscopy ]
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): NCT00376831
|Soroka Medical Center|
|Beer Sheva, Israel, 84101|
|Principal Investigator:||pavel krugliak, md. professor||Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel|