Blood Pressure, Electroconvulsive Therapy
Conditions
Keywords
Anesthesia
Brief summary
Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized with the administration of alfentanil as part of their anesthetic regimen. This study proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved drug used on a daily basis by anesthesiologists on other surgeries so this is not a new indication.
Detailed description
Electroconvulsive therapy is associated with brief hemodynamic alterations that in some patients may be well outside the range of normalcy and potentially dangerous to the patient (Duma A, et al). This cardiovascular response is caused by activation of the autonomic nervous system and consists of an initial parasympathetic response rapidly followed by sympathetically mediated tachycardia and hypertension. The ultra-short acting synthetic opioid alfentanil has a rapid onset and duration of action that mirrors the duration of hemodynamic perturbation associated with Electroconvulsive Therapy (ECT) while having minimal or no effect on the duration or quality of the seizure. This drug may be effective in blunting the hemodynamic perturbations associated with ECT with a minimal amount of side effects.
Interventions
DRUGAlfentanil
Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
DRUGPlacebos
Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
study med prepared by a provider not involved in the anesthesia care of the subject
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> /=18 years * Males or females * Anticipating electroconvulsive therapy to treat refractory depressive disorder
Exclusion criteria
* Under the age of 18 * Allergy to alfentanil * Allergy to other standard anesthetic medications utilized in the course of ECT (glycopyrrolate, methohexital, and succinylcholine) * History of malignant hyperthermia * History of severe airway obstruction, bronchospasm or laryngospasm * History of recent myocardial infarction, ventricular arrhythmia * Adverse reaction to ECT requiring premedication with lidocaine or atropine * Non-English speaking * Patients unable to consent for themselves * Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure Change | Baseline and up to 90 minutes | comparison of Systolic blood pressure changes alfentanil vs placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Baseline and up to 15 seconds | comparison of heart rate change alfentanil vs placebo |
| Maximum Heart Rate | Baseline and up to 90 minutes | comparison of heart rate change alfentanil vs placebo |
| Minimum Heart Rate | Baseline and up to 90 minutes | comparison of heart rate change alfentanil vs placebo |
| Doses of Antihypertensive Medication | 90 minutes | comparison of amounts of medications needed to treat blood pressure between the 2 groups |
| Diastolic Blood Pressure Change | Baseline and up to 90 minutes | comparison of diastolic blood pressure change alfentanil vs placebo |
| Total Time Subject Spent In-Room | up to 90 minutes | comparison of amounts time spent in-room between the 2 groups |
| Severity of Headache in the Post Anesthesia Care Unit | up to 90 minutes | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst |
| Satisfaction With the Anesthetic Post-procedure | up to 90 minutes | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst |
| Time to Return of Spontaneous Ventilation | up to 90 minutes | time to return to breathing without assistance |
Countries
United States
Participant flow
Pre-assignment details
One Subject Withdrew before randomization
Participants by arm
| Arm | Count |
|---|---|
| Alfentanil Then Placebo Arm 1 Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed | 49 |
| Placebo Then Alfentanil Arm 2 Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention A / B | Lost to Follow-up | 2 | 3 |
| First Intervention A / B | Withdrawal by Subject | 1 | 0 |
| Second Intervention B/A | Exclusion criteria | 0 | 1 |
| Second Intervention B/A | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo Then Alfentanil Arm 2 | Alfentanil Then Placebo Arm 1 |
|---|---|---|---|
| Age, Continuous | 51.621 years STANDARD_DEVIATION 15.57 | 51.94 years STANDARD_DEVIATION 13.96 | 51.34 years STANDARD_DEVIATION 17.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 48 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Height (cm) | 167.58 Centimeters STANDARD_DEVIATION 10.67 | 167.59 Centimeters STANDARD_DEVIATION 10.25 | 167.57 Centimeters STANDARD_DEVIATION 11.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 94 Participants | 46 Participants | 48 Participants |
| Region of Enrollment United States | 99 Participants | 50 Participants | 49 Participants |
| Sex: Female, Male Female | 67 Participants | 32 Participants | 35 Participants |
| Sex: Female, Male Male | 32 Participants | 18 Participants | 14 Participants |
| Weight (kg) | 85.405 kilograms STANDARD_DEVIATION 30.05 | 85.156 kilograms STANDARD_DEVIATION 27.33 | 86.28 kilograms STANDARD_DEVIATION 31.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 87 | 1 / 87 |
| other Total, other adverse events | 0 / 87 | 0 / 87 |
| serious Total, serious adverse events | 1 / 87 | 1 / 87 |
Outcome results
Primary
Systolic Blood Pressure Change
comparison of Systolic blood pressure changes alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Systolic Blood Pressure Change | 22.011 mmHg | Standard Deviation 36.968 |
| Placebo | Systolic Blood Pressure Change | 38.908 mmHg | Standard Deviation 33.50864 |
Secondary
Diastolic Blood Pressure Change
comparison of diastolic blood pressure change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Diastolic Blood Pressure Change | 15.26 mmHg | Standard Deviation 23.3848507043 |
| Placebo | Diastolic Blood Pressure Change | 23.34 mmHg | Standard Deviation 24.4 |
Secondary
Doses of Antihypertensive Medication
comparison of amounts of medications needed to treat blood pressure between the 2 groups
Time frame: 90 minutes
Population: Patients had already been discharged from the PACU at 90 minutes time interval and data were not collected
Secondary
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 30 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Heart Rate | 37.48 Beats per Minute | Standard Deviation 25.46 |
| Placebo | Heart Rate | 36.93 Beats per Minute | Standard Deviation 25.46 |
Secondary
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 15 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Heart Rate | 26.00 Beats per Minute | Standard Deviation 19.823 |
| Placebo | Heart Rate | 28.197674418604 Beats per Minute | Standard Deviation 21.486 |
Secondary
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: 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
Secondary
Maximum Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Maximum Heart Rate | 44.33 Beats per Minute | Standard Deviation 24.274 |
| Placebo | Maximum Heart Rate | 49.66 Beats per Minute | Standard Deviation 26.629 |
Secondary
Minimum Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Minimum Heart Rate | 12.74 Beats per Minute | Standard Deviation 14.674 |
| Placebo | Minimum Heart Rate | 7.08 Beats per Minute | Standard Deviation 19.221 |
Secondary
Satisfaction With the Anesthetic Post-procedure
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Satisfaction With the Anesthetic Post-procedure | 8 score on a scale | Standard Deviation 2.449 |
| Placebo | Satisfaction With the Anesthetic Post-procedure | 8.033 score on a scale | Standard Deviation 2.505 |
Secondary
Severity of Headache in the Post Anesthesia Care Unit
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Severity of Headache in the Post Anesthesia Care Unit | 2 score on a scale | Standard Deviation 2.887 |
| Placebo | Severity of Headache in the Post Anesthesia Care Unit | 2.467 score on a scale | Standard Deviation 3.038 |
Secondary
Time to Return of Spontaneous Ventilation
time to return to breathing without assistance
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Time to Return of Spontaneous Ventilation | 8.17 Minutes | Standard Deviation 2.483 |
| Placebo | Time to Return of Spontaneous Ventilation | 7.25 Minutes | Standard Deviation 1.869 |
Secondary
Total Time Subject Spent In-Room
comparison of amounts time spent in-room between the 2 groups
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alfentanil | Total Time Subject Spent In-Room | 17.51 Minutes | Standard Deviation 4.64 |
| Placebo | Total Time Subject Spent In-Room | 16.43 Minutes | Standard Deviation 3.94 |