Trial Outcomes & Findings for Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time (NCT NCT01567852)

Last Updated: 2014-12-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 hour

Results posted on

2014-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Then Methohexital (Alternating Each Trial) 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	Methohexital Then Ketamine (Alternating Each Trial) 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
Overall Study STARTED	8	12
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine Then Methohexital (Alternating Each Trial) 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	Methohexital Then Ketamine (Alternating Each Trial) 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
Overall Study Withdrawal by Subject	3	6
Overall Study ECT discontinued	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine First n=8 Participants 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	Methohexital First n=12 Participants 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 n=20 Participants Total of all reporting groups
Age, Continuous	51.75 years STANDARD_DEVIATION 13.46 • n=5 Participants	54 years STANDARD_DEVIATION 22.63 • n=7 Participants	52.65 years STANDARD_DEVIATION 17.17 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 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

Outcome measures

Outcome measures
Measure	Ketamine Inductions n=19 Participants Patients receiving Ketamine inductions for ECT	Methohexital Inductions n=19 Participants Patients receiving methohexital for inductions
Re-orientation Time	24.5 minutes Standard Deviation 1.6	19.5 minutes Standard Deviation 1.6

PRIMARY outcome

Timeframe: 1 hour

Population: Please see description from outcome 1

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.

Outcome measures

Outcome measures
Measure	Ketamine Inductions n=19 Participants Patients receiving Ketamine inductions for ECT	Methohexital Inductions n=19 Participants Patients receiving methohexital for inductions
Recovery Time	28.6 minutes Standard Deviation 2.0	27.2 minutes Standard Deviation 1.7

Adverse Events

Ketamine Inductions

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Methohexital Inductions

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine Inductions n=35 participants at risk Number of trials receiving ketamine inductions. Each trial is one induction.	Methohexital Inductions n=34 participants at risk Number of trials receiving methohexital inductions. Each trial is one induction
Gastrointestinal disorders Nausea	14.3% 5/35 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.	2.9% 1/34 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.
Psychiatric disorders Anxiety	2.9% 1/35 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.	2.9% 1/34 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.
Psychiatric disorders Dysphoria	11.4% 4/35 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.	0.00% 0/34 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.
General disorders Headache	5.7% 2/35 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.	2.9% 1/34 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.
General disorders Anesthesia Awareness	0.00% 0/35 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.	2.9% 1/34 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.
General disorders Dizziness	8.6% 3/35 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.	5.9% 2/34 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.
Psychiatric disorders Agitation	2.9% 1/35 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.	0.00% 0/34 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.
General disorders Lethargy	5.7% 2/35 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.	5.9% 2/34 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.
Psychiatric disorders Hallucination	2.9% 1/35 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.	0.00% 0/34 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.

Additional Information

Dr. Tony Yen

University of NewMexico

Phone: 505-272-2610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place