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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

Tracking Information
First Submitted Date  ICMJE September 14, 2006
First Posted Date  ICMJE September 15, 2006
Last Update Posted Date August 10, 2007
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2007)
Recovery time [ Time Frame: 24 hours following colonoscopy ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
Recovery time
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2007)
  • Sedative effect [ Time Frame: 24 hours following colonoscopy ]
  • Patient compliance [ Time Frame: 24 hours following colonoscopy ]
  • Side effects [ Time Frame: 24 hours following colonoscopy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
  • Sedative effect
  • Patient compliance
  • Side effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonoscopy
  • Conscious Sedation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 0
    fentanyl
    Intervention: Drug: Midazolam, Fentanyl
  • Active Comparator: 1
    ketamine
    Intervention: Drug: KETAMINE, MIDAZOLAM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2007)
91
Original Enrollment  ICMJE
 (submitted: September 14, 2006)
120
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376831
Other Study ID Numbers  ICMJE SOR440806CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: pavel krugliak, md. professor Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
PRS Account Soroka University Medical Center
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP