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Proper Dosage of Ketamine in Intravenous Regional Anesthesia

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ClinicalTrials.gov Identifier: NCT00221871
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : October 11, 2006
Sponsor:
Information provided by:
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date October 11, 2006
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proper Dosage of Ketamine in Intravenous Regional Anesthesia
Official Title  ICMJE Proper Dosage of Intravenous Ketamine When Used as an Adjuvant to Lidocaine in Intravenous Regional Anesthesia (IVRA).
Brief Summary Ketamine added to Lidocaine can increase duration of pain relief following intraveonous regional anesthesia (IVRA). The purpose of this dose response study is to determine the minimum effective dosage of intravenous Ketamine, added to 3 mg/kg of Lidocaine. We anticipate that one dosage will provide us with the proper balance between sufficient anesthesia and minimal side effects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Pain.
Intervention  ICMJE Drug: Different dosages of Ketamine
Study Arms  ICMJE Not Provided
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 Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 18-70
  2. Weight: 50-100 kg
  3. ASA: I, II, III
  4. Carpal tunnel syndrome surgery, tenolysis, ganglion removal or any peripheral hand surgery that can be done by IVRA.

Exclusion Criteria:

  1. Contraindication to IVRA such as sickle cell disease.
  2. Any known hypersensitivity reaction to Ketamine.
  3. History of chronic pain or regular medication with analgesics.
  4. History of opioid dependence.
  5. Drug of alcohol abuse.
  6. Psychiatric disorder.
  7. Allergy to acetaminophen or codeine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00221871
Other Study ID Numbers  ICMJE UHN02-0233-A
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 University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colin McCartney, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date September 2005

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