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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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Enrollment: | 91 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
0: Active Comparator
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
|
|
1: Active Comparator
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
| Study ID Numbers: | SOR440806CTIL |
| Study First Received: | September 14, 2006 |
| Last Updated: | August 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00376831 History of Changes |
| Health Authority: | Israel: Ministry of Health |
|
colonoscopy conscious sedation midazolam ketamine fentanyl |
|
Fentanyl Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Excitatory Amino Acid Agents Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Ketamine Analgesics Analgesics, Opioid |
Excitatory Amino Acid Antagonists Anesthetics, Intravenous Tranquilizing Agents Central Nervous System Depressants Narcotics Midazolam Pharmacologic Actions Anesthetics, Dissociative Adjuvants, Anesthesia Anesthetics, General GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |
