Trial Outcomes & Findings for Pre-medication With Alfentanil vs Placebo During ECT (NCT NCT03359395)

NCT ID: NCT03359395

Last Updated: 2021-07-08

Results Overview

comparison of Systolic blood pressure changes alfentanil vs placebo

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and up to 90 minutes
• Results posted on: 2021-07-08

Participant Flow

One Subject Withdrew before randomization

Participant milestones

Measure	Alfentanil Then Placebo Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo Then Afentanil Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
First Intervention A / B STARTED	49	50
First Intervention A / B COMPLETED	46	47
First Intervention A / B NOT COMPLETED	3	3
Second Intervention B/A STARTED	46	47
Second Intervention B/A COMPLETED	43	44
Second Intervention B/A NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Alfentanil Then Placebo Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo Then Afentanil Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
First Intervention A / B Withdrawal by Subject	1	0
First Intervention A / B Lost to Follow-up	2	3
Second Intervention B/A Exclusion criteria	0	1
Second Intervention B/A Lost to Follow-up	3	2

Baseline Characteristics

Pre-medication With Alfentanil vs Placebo During ECT

Baseline characteristics by cohort

Measure	Alfentanil Then Placebo Arm 1 n=49 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo Then Alfentanil Arm 2 n=50 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Total n=99 Participants Total of all reporting groups
Age, Continuous	51.34 years STANDARD_DEVIATION 17.10 • n=5 Participants	51.94 years STANDARD_DEVIATION 13.96 • n=7 Participants	51.621 years STANDARD_DEVIATION 15.57 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	1 Participants n=7 Participants	1 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	46 Participants n=7 Participants	94 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
Region of Enrollment United States	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Height (cm)	167.57 Centimeters STANDARD_DEVIATION 11.31 • n=5 Participants	167.59 Centimeters STANDARD_DEVIATION 10.25 • n=7 Participants	167.58 Centimeters STANDARD_DEVIATION 10.67 • n=5 Participants
Weight (kg)	86.28 kilograms STANDARD_DEVIATION 31.57 • n=5 Participants	85.156 kilograms STANDARD_DEVIATION 27.33 • n=7 Participants	85.405 kilograms STANDARD_DEVIATION 30.05 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 90 minutes

comparison of Systolic blood pressure changes alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Systolic Blood Pressure Change	22.011 mmHg Standard Deviation 36.968	38.908 mmHg Standard Deviation 33.50864

SECONDARY outcome

Timeframe: Baseline and up to 90 minutes

comparison of diastolic blood pressure change alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Diastolic Blood Pressure Change	15.26 mmHg Standard Deviation 23.3848507043	23.34 mmHg Standard Deviation 24.40

SECONDARY outcome

Timeframe: Baseline and up to 15 seconds

comparison of heart rate change alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Heart Rate	26.00 Beats per Minute Standard Deviation 19.823	28.197674418604 Beats per Minute Standard Deviation 21.486

SECONDARY outcome

Timeframe: Baseline and up to 30 seconds

comparison of heart rate change alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Heart Rate	37.48 Beats per Minute Standard Deviation 25.46	36.93 Beats per Minute Standard Deviation 25.46

SECONDARY outcome

Timeframe: 90 minutes

Population: Patients had already been discharged from the Post Anesthesia Care Unit (PACU) at 90 minutes time interval and data were not collected

comparison of heart rate change alfentanil vs placebo

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 90 minutes

comparison of heart rate change alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Maximum Heart Rate	44.33 Beats per Minute Standard Deviation 24.274	49.66 Beats per Minute Standard Deviation 26.629

SECONDARY outcome

Timeframe: Baseline and up to 90 minutes

comparison of heart rate change alfentanil vs placebo

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Minimum Heart Rate	12.74 Beats per Minute Standard Deviation 14.674	7.08 Beats per Minute Standard Deviation 19.221

SECONDARY outcome

Timeframe: 90 minutes

Population: Patients had already been discharged from the PACU at 90 minutes time interval and data were not collected

comparison of amounts of medications needed to treat blood pressure between the 2 groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 90 minutes

time to return to breathing without assistance

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Time to Return of Spontaneous Ventilation	8.17 Minutes Standard Deviation 2.483	7.25 Minutes Standard Deviation 1.869

SECONDARY outcome

Timeframe: up to 90 minutes

comparison of amounts time spent in-room between the 2 groups

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Total Time Subject Spent In-Room	17.51 Minutes Standard Deviation 4.640	16.43 Minutes Standard Deviation 3.940

SECONDARY outcome

Timeframe: up to 90 minutes

comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Severity of Headache in the Post Anesthesia Care Unit	2 score on a scale Standard Deviation 2.887	2.467 score on a scale Standard Deviation 3.038

SECONDARY outcome

Timeframe: up to 90 minutes

comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst

Outcome measures

Measure	Alfentanil n=87 Participants Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 Participants Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Satisfaction With the Anesthetic Post-procedure	8 score on a scale Standard Deviation 2.449	8.033 score on a scale Standard Deviation 2.505

Adverse Events

Alfentanil

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Alfentanil n=87 participants at risk Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 participants at risk Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Social circumstances Suicide	1.1% 1/87 • Number of events 1 • 24 hours Death by suicide the day after one of their electroconvulsive therapy (ECT) procedures was completed - at which time they received Alfentanil during that ECT	1.1% 1/87 • Number of events 1 • 24 hours Death by suicide the day after one of their electroconvulsive therapy (ECT) procedures was completed - at which time they received Alfentanil during that ECT

Other adverse events

Measure	Alfentanil n=87 participants at risk Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed	Placebo n=87 participants at risk Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Social circumstances Suicide	0.00% 0/87 • 24 hours Death by suicide the day after one of their electroconvulsive therapy (ECT) procedures was completed - at which time they received Alfentanil during that ECT	0.00% 0/87 • 24 hours Death by suicide the day after one of their electroconvulsive therapy (ECT) procedures was completed - at which time they received Alfentanil during that ECT

Additional Information

T. Quinn McCutchen, MD

Wake Forest Health Science

Phone: 336.716.4498

Email: tmccutch@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place