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

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT01567852
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.1

Study Details

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	Phase
Post-anesthesia Recovery; Orientation	Drug: Ketamine; Drug: Methohexital	N/A

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
• 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: Aug 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

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 [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 [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of New Mexico
• ClinicalTrials.gov Identifier: NCT01567852
• Other Study ID Numbers: HRRC#: 11-236
• First Posted: Mar 30, 2012
• Last Update Posted: Dec 30, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by University of New Mexico: orientation; post-anesthesia recovery; electroconvulsive therapy
• Additional relevant MeSH terms: Ketamine; Methohexital

Study Results

Participant Flow

Arm/Group Title	Ketamine Then Methohexital (Alternating Each Trial)	Methohexital Then Ketamine (Alternating Each Trial)
Arm/Group Description	This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends). Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect	This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends). Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Period Title: Overall Study
STARTED	8	12
COMPLETED	4	5
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Ketamine First	Methohexital First	Total
Arm/Group Description	This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect Methohexital: Methohexital (1-1.5mg/kg) will be given for induction	This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect Methohexital: Methohexital (1-1.5mg/kg) will be given for induction	Total of all reporting groups
Overall Participants	8	12	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.75 (13.46)	54 (22.63)	52.65 (17.17)
Sex: Female, Male (Count of Participants)
Female	5 62.5%	7 58.3%	12 60%
Male	3 37.5%	5 41.7%	8 40%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	8 100%	11 91.7%	19 95%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 8.3%	1 5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 25%	3 25%	5 25%
Not Hispanic or Latino	6 75%	8 66.7%	14 70%
Unknown or Not Reported	0 0%	1 8.3%	1 5%

Outcome Measures

1. Primary Outcome

Title	Re-orientation Time
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials

Arm/Group Title	Ketamine Inductions	Methohexital Inductions
Arm/Group Description	Patients receiving Ketamine inductions for ECT	Patients receiving methohexital for inductions
Measure Participants	19	19
Mean (Standard Deviation) [minutes]	24.5 (1.6)	19.5 (1.6)

2. Primary Outcome

Title	Recovery Time
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

Please see description from outcome 1

Arm/Group Title	Ketamine Inductions	Methohexital Inductions
Arm/Group Description	Patients receiving Ketamine inductions for ECT	Patients receiving methohexital for inductions
Measure Participants	19	19
Mean (Standard Deviation) [minutes]	28.6 (2.0)	27.2 (1.7)

Adverse Events

Adverse Event Reporting Description	Due to the cross-over, the same participant experienced different adverse effects according to which medication they received for induction. Hence, the number of adverse events is reported per trial (each trial is one induction) instead of per participant. There was a total of 35 trials with ketamine, and 34 trials with methohexital.
Arm/Group Title	Ketamine Inductions		Methohexital Inductions
Arm/Group Description	Number of trials receiving ketamine inductions. Each trial is one induction.		Number of trials receiving methohexital inductions. Each trial is one induction
All Cause Mortality
	Ketamine Inductions		Methohexital Inductions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketamine Inductions		Methohexital Inductions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Ketamine Inductions		Methohexital Inductions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/35 (54.3%)		8/34 (23.5%)
Gastrointestinal disorders
Nausea	5/35 (14.3%)		1/34 (2.9%)
General disorders
Headache	2/35 (5.7%)		1/34 (2.9%)
Anesthesia Awareness	0/35 (0%)		1/34 (2.9%)
Dizziness	3/35 (8.6%)		2/34 (5.9%)
Lethargy	2/35 (5.7%)		2/34 (5.9%)
Psychiatric disorders
Anxiety	1/35 (2.9%)		1/34 (2.9%)
Dysphoria	4/35 (11.4%)		0/34 (0%)
Agitation	1/35 (2.9%)		0/34 (0%)
Hallucination	1/35 (2.9%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.