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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376831
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : August 10, 2007
Sponsor:
Information provided by:
Soroka University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colonoscopy Conscious Sedation Drug: Midazolam, Fentanyl Drug: KETAMINE, MIDAZOLAM Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Recovery time [ Time Frame: 24 hours following colonoscopy ]

Secondary Outcome Measures :
  1. Sedative effect [ Time Frame: 24 hours following colonoscopy ]
  2. Patient compliance [ Time Frame: 24 hours following colonoscopy ]
  3. Side effects [ Time Frame: 24 hours following colonoscopy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hypersensitivity to benzodiazepines
  2. Hypersensitivity to benzyl alcohol
  3. Hypersensitivity to ketamine
  4. Hypersensitivity to opiates
  5. Pregnancy
  6. Uncontrolled hypertension
  7. Myocardial infarct in the last 6 months
  8. CVA
  9. Chronic pulmonary disease
  10. Renal failure
  11. Chronic liver disease (CHILD B or C)
  12. Elevated ICP, cerebral hemorrhage or cranial SOL.
  13. Hypovolemic shock
  14. Glaucoma
  15. Mental illness
  16. Drug or alcohol addiction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376831


Locations
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Israel
Soroka Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: pavel krugliak, md. professor Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
More Information
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ClinicalTrials.gov Identifier: NCT00376831    
Other Study ID Numbers: SOR440806CTIL
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: August 10, 2007
Last Verified: August 2007
Keywords provided by Soroka University Medical Center:
colonoscopy
conscious sedation
midazolam
ketamine
fentanyl
Additional relevant MeSH terms:
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Fentanyl
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
 Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents