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

NCT01567852 | Completed Results DMC

• 1 other identifier: HRRC#: 11-236
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-anesthesia Recovery; Orientation

Keywords

orientation; post-anesthesia recovery; electroconvulsive therapy

Outcome Measures

Primary Outcomes (2)

• Re-orientation Time

  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

  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

Study Arms (2)

Ketamine First

EXPERIMENTAL

This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine

Drug: Ketamine; Drug: Methohexital

Methohexital First

EXPERIMENTAL

This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.

Drug: Ketamine; Drug: Methohexital

Interventions

Ketamine DRUG

Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Ketamine First; Methohexital First

Methohexital DRUG

Methohexital (1.5mg/kg) will be given for induction

Ketamine First; Methohexital First

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Orientation, Spatial

Interventions

Ketamine; Methohexital

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Tony Yen
• Organization: University of NewMexico

tyen@salud.unm.edu

505-272-2610

Study Officials

• Tony Yen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 30, 2014
• Results First Posted: December 30, 2014

Record last verified: 2014-06

Locations

US (1)