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| Sponsor: | Soroka University Medical Center |
|---|---|
| Information provided by: | Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00376831 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colonoscopy Conscious Sedation |
Drug: Midazolam, Fentanyl Drug: KETAMINE, MIDAZOLAM |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Enrollment: | 91 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 0
fentanyl
|
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
ketamine
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00376831 History of Changes |
| Other Study ID Numbers: | SOR440806CTIL |
| Study First Received: | September 14, 2006 |
| Last Updated: | August 9, 2007 |
| Health Authority: | Israel: Ministry of Health |
|
colonoscopy conscious sedation midazolam ketamine fentanyl |
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Ketamine Fentanyl Midazolam Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Hypnotics and Sedatives GABA Modulators GABA Agents Narcotics Analgesics, Opioid |
