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

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00376831
First received: September 14, 2006
Last updated: August 9, 2007
Last verified: August 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

Secondary Outcome Measures:
  • Sedative effect [ Time Frame: 24 hours following colonoscopy ]
  • Patient compliance [ Time Frame: 24 hours following colonoscopy ]
  • Side effects [ Time Frame: 24 hours following colonoscopy ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376831

Locations
Israel
Soroka Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: pavel krugliak, md. professor Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
  More Information

No publications provided

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

Keywords provided by Soroka University Medical Center:
colonoscopy
conscious sedation
midazolam
ketamine
fentanyl

Additional relevant MeSH terms:
Fentanyl
Ketamine
Midazolam
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014