Proper Dosage of Ketamine in Intravenous Regional Anesthesia

Proper Dosage of Intravenous Ketamine When Used as an Adjuvant to Lidocaine in Intravenous Regional Anesthesia (IVRA).

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.

Study Overview

• Status: Unknown
• Conditions: Pain.
• Intervention / Treatment: Drug: Different dosages of Ketamine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • Recruiting
      • University Health Network
      • Contact: Filomena Valle-Leutri, BSc; Phone Number: 2016 (416)603-5800; Email: filomena.valle-leutri@uhn.on.ca
      • Principal Investigator: Colin McCartney, MD
      • Sub-Investigator: Philip Peng, MD
      • Sub-Investigator: Paul Tumber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Colin McCartney, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion: December 6, 2022
• Study Completion: January 1, 2005

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): October 11, 2006
• Last Update Submitted That Met QC Criteria: October 10, 2006
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: UHN02-0233-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No