- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567852
Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
December 15, 2014 updated by: University of New Mexico
The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time
When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine First
This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
|
Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
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.
|
Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital (1.5mg/kg) will be given for induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tony Yen, MD, University of New Mexico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 28, 2012
First Submitted That Met QC Criteria
March 29, 2012
First Posted (Estimate)
March 30, 2012
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 15, 2014
Last Verified
June 1, 2014
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
- Methohexital
Other Study ID Numbers
- HRRC#: 11-236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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