The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
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.
|Colonoscopy Conscious Sedation||Drug: Midazolam, Fentanyl Drug: KETAMINE, MIDAZOLAM||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
- 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 ]
|Study Start Date:||January 2007|
|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
Please refer to this study by its ClinicalTrials.gov identifier: 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|