Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01567852
First received: March 28, 2012
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.


Condition Intervention
Post-anesthesia Recovery
Orientation
Drug: Ketamine
Drug: Methohexital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Re-orientation Time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients will be reoriented to baseline status more quickly with ketamine than with methohexital

  • Recovery Time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients undergoing ECT treatments will recover in the post-anesthesia care unit more quickly after a ketamine induction compared to a methohexital induction


Enrollment: 19
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine First
This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
Drug: Ketamine
Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Drug: Methohexital
Methohexital (1.5mg/kg) will be given for induction
Experimental: Methohexital First
This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
Drug: Ketamine
Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Drug: Methohexital
Methohexital (1.5mg/kg) will be given for induction

Detailed Description:

ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.

Exclusion Criteria:

  • patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3;
  • patients with a known allergic reactions to methohexital , ketamine and succinylcholine;
  • patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension;
  • patients with uncontrolled severe hypertension.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01567852

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Tony Yen, MD University of New Mexico
  More Information

No publications provided

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01567852     History of Changes
Other Study ID Numbers: HRRC#: 11-236
Study First Received: March 28, 2012
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
orientation
post-anesthesia recovery
electroconvulsive therapy

Additional relevant MeSH terms:
Ketamine
Methohexital
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 30, 2014