Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
This study is currently recruiting participants.
Verified March 2012 by University of New Mexico
Sponsor:
University of New Mexico
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01567852
First received: March 28, 2012
Last updated: March 29, 2012
Last verified: March 2012
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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
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567852
Contacts
| Contact: Tony Yen, MD | 505-272-2610 | tyen@salud.unm.edu |
Locations
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Tony Yen, MD 505-272-2610 tyen@salud.unm.edu | |
| Sub-Investigator: Chris Abbott, MD | |
| Principal Investigator: Tony Yen, MD | |
| Sub-Investigator: Nicholas Lam, MD | |
| Sub-Investigator: John Rask, MD | |
| Sub-Investigator: Mary Billstrand, MD | |
| Sub-Investigator: Jake Rothfork, MD | |
| Sub-Investigator: Ronald Schrader, PhD | |
| Sub-Investigator: Tim Petersen, PhD | |
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: | March 29, 2012 |
| 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 Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013