Neuromuscular Blockade
Conditions
Keywords
Electroconvulsive Therapy, Neuromuscular Blockade
Brief summary
The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT.
Detailed description
The proposed study is a single center, randomized, double-blind (patients, psychiatrists and outcome assessor), cross-over clinical trial comparing the recovery of neuromuscular blockade from rocuronium with reversal of sugammadex to succinylcholine in participants receiving ECT. The primary outcome will be the measurement of time when the first train-of-four (TOF) twitch (T1) returns to 90% of baseline. The secondary aims are to document the safety (adverse event rates) of rocuronium/sugammadex compared to succinylcholine in ECT patients. The exploratory aims are to establish the perioperative efficacy and efficiency of sugammadex reversal of rocuronium in ECT procedures in comparison with succinylcholine.
Interventions
DRUGGroup A. Muscle relaxant #1: rocuronium + sugammadex; Muscle relaxant #2: succinylcholine +saline
The participants will be randomized to start with Muscle relaxant #1 in the first study treatment, and will switch to Muscle relaxant #2 in the second study treatment period.
DRUGGroup B. Muscle relaxant #2: succinylcholine +saline; Muscle relaxant #1: rocuronium + sugammadex;
The participants will be randomized to start with Muscle relaxant #2 in the first study treatment, and will switch to Muscle relaxant #1 in the second study treatment period.
Sponsors
Merck Sharp & Dohme LLC
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.
Intervention model description
The participants will be randomized to one of the two drug groups to start with, and will switch to the other group for the next treatment period. For the study, each participant will take two treatments in a random order: (1) rocuronium to be reversed by sugammadex, and (2) succinylcholine plus normal saline placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible and scheduled for ECT * Has the capacity to consent for the study
Exclusion criteria
* Any acute major organ failure in the last 30 days * Any known or suspected neuromuscular disorders * Any history of allergic reaction or intolerance to sugammadex, rocuronium, or succinylcholine * Any conditions with severe renal impairment, including those requiring dialysis * Anyone currently taking lithium * Anyone currently taking hormonal contraceptives * Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time of T1 to 90% Baseline | 30 minutes | The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment or Emergent Adverse Events of the Drugs | 24 hours after the procedure | To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A rocuronium + sugammadex / succinylcholine + normal saline
Group A. Muscle relaxant #1: rocuronium + sugammadex; Muscle relaxant #2: succinylcholine +saline: The participants will be randomized to start with Muscle relaxant #1 in the first study treatment, and will switch to Muscle relaxant #2 in the second study treatment period. | 23 |
| Group B succinylcholine + normal saline / rocuronium + sugammadex
Group B. Muscle relaxant #2: succinylcholine +saline; Muscle relaxant #1: rocuronium + sugammadex;: The participants will be randomized to start with Muscle relaxant #2 in the first study treatment, and will switch to Muscle relaxant #1 in the second study treatment period. | 21 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Period | technical issues in data collection Technical issues | 0 | 1 |
| First Period | Withdrawal by Subject | 1 | 3 |
| Second Period | Technical issues | 0 | 1 |
| Second Period | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Group A | Total | Group B |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 37 Participants | 19 Participants |
| Race/Ethnicity, Customized Africa American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized More than 1 race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized unreported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 22 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 9 / 40 | 14 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Recovery Time of T1 to 90% Baseline
The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT).
Time frame: 30 minutes
Population: Subjects completed the two periods with each study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muscle Relaxant #1 | Recovery Time of T1 to 90% Baseline | 6.79 minutes | Standard Deviation 2.08 |
| Muscle Relaxant #2 | Recovery Time of T1 to 90% Baseline | 10.97 minutes | Standard Deviation 3.06 |
Secondary
Number of Participants With Treatment or Emergent Adverse Events of the Drugs
To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population
Time frame: 24 hours after the procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Muscle Relaxant #1 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Nausea | 1 Participants |
| Muscle Relaxant #1 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Myalgia | 1 Participants |
| Muscle Relaxant #1 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Headache | 7 Participants |
| Muscle Relaxant #2 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Nausea | 3 Participants |
| Muscle Relaxant #2 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Myalgia | 2 Participants |
| Muscle Relaxant #2 | Number of Participants With Treatment or Emergent Adverse Events of the Drugs | Headache | 9 Participants |