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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 | Active Comparator | fentanyl |
|
| 1 | Active Comparator | ketamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam, Fentanyl | Drug | fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | 24 hours following colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Sedative effect | 24 hours following colonoscopy | |
| Patient compliance | 24 hours following colonoscopy | |
| Side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| pavel krugliak, md. professor | Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | 84101 | Israel |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| KETAMINE, MIDAZOLAM | Drug | Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg |
|
| 24 hours following colonoscopy |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |