The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

NCT00376831 | Completed Phase 4

• 1 other identifier: SOR440806CTIL
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy; Conscious Sedation

Keywords

colonoscopy; conscious sedation; midazolam; ketamine; fentanyl

Outcome Measures

Primary Outcomes (1)

• Recovery time

  24 hours following colonoscopy

Secondary Outcomes (3)

• Sedative effect

  24 hours following colonoscopy

• Patient compliance

  24 hours following colonoscopy

• Side effects

  24 hours following colonoscopy

Study Arms (2)

0

ACTIVE COMPARATOR

fentanyl

Drug: Midazolam, Fentanyl

1

ACTIVE COMPARATOR

ketamine

Drug: KETAMINE, MIDAZOLAM

Interventions

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

0

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.

You may not qualify if:

• Hypersensitivity to benzodiazepines
• Hypersensitivity to benzyl alcohol
• Hypersensitivity to ketamine
• Hypersensitivity to opiates
• Pregnancy
• Uncontrolled hypertension
• Myocardial infarct in the last 6 months
• CVA
• Chronic pulmonary disease
• Renal failure
• Chronic liver disease (CHILD B or C)
• Elevated ICP, cerebral hemorrhage or cranial SOL.
• Hypovolemic shock
• Glaucoma
• Mental illness

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Interventions

Midazolam; Fentanyl; Ketamine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• pavel krugliak, md. professor

  Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 15, 2006
• Study Start: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 10, 2007

Record last verified: 2007-08

Locations

IL (1)