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

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ClinicalTrials.gov Identifier: NCT01567852
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Post-anesthesia Recovery Orientation Drug: Ketamine Drug: Methohexital

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : August 2011
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Re-orientation Time [ Time Frame: 1 hour ]
    Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.

  2. Recovery Time [ Time Frame: 1 hour ]
    Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01567852     History of Changes
Other Study ID Numbers: HRRC#: 11-236
First Posted: March 30, 2012    Key Record Dates
Results First Posted: December 30, 2014
Last Update Posted: December 30, 2014
Last Verified: June 2014

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
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