Trial Outcomes & Findings for Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT) (NCT NCT03532178)
NCT ID: NCT03532178
Last Updated: 2023-09-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
30 minutes
Results posted on
2023-09-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Period
STARTED
|
23
|
21
|
|
First Period
COMPLETED
|
22
|
17
|
|
First Period
NOT COMPLETED
|
1
|
4
|
|
Second Period
STARTED
|
22
|
17
|
|
Second Period
COMPLETED
|
21
|
15
|
|
Second Period
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Period
Withdrawal by Subject
|
1
|
3
|
|
First Period
technical issues in data collection Technical issues
|
0
|
1
|
|
Second Period
Withdrawal by Subject
|
1
|
1
|
|
Second Period
Technical issues
|
0
|
1
|
Baseline Characteristics
Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Baseline characteristics by cohort
| Measure |
Group A
n=23 Participants
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.
|
Group B
n=21 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Africa American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
unreported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Subjects completed the two periods with each study medication
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).
Outcome measures
| Measure |
Muscle Relaxant #1
n=36 Participants
rocuronium 0.6 mg/kg + reversal with sugammadex 4 mg/kg
|
Muscle Relaxant #2
n=36 Participants
succinylcholine 1.0 mg/kg + reversal with normal saline as the placebo agent
|
|---|---|---|
|
Recovery Time of T1 to 90% Baseline
|
6.79 minutes
Standard Deviation 2.08
|
10.97 minutes
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: 24 hours after the procedureTo document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population
Outcome measures
| Measure |
Muscle Relaxant #1
n=40 Participants
rocuronium 0.6 mg/kg + reversal with sugammadex 4 mg/kg
|
Muscle Relaxant #2
n=40 Participants
succinylcholine 1.0 mg/kg + reversal with normal saline as the placebo agent
|
|---|---|---|
|
Number of Participants With Treatment or Emergent Adverse Events of the Drugs
Nausea
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment or Emergent Adverse Events of the Drugs
Myalgia
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment or Emergent Adverse Events of the Drugs
Headache
|
7 Participants
|
9 Participants
|
Adverse Events
Rocuronium + Sugammadex
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Succinylcholine + Normal Saline
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rocuronium + Sugammadex
n=40 participants at risk
rocuronium 0.6 mg/kg + reversal with sugammadex 4 mg/kg
|
Succinylcholine + Normal Saline
n=40 participants at risk
succinylcholine 1.0 mg/kg + reversal with normal saline as the placebo agent
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 24 hours following the treatment
|
7.5%
3/40 • Number of events 3 • 24 hours following the treatment
|
|
Nervous system disorders
Headache
|
17.5%
7/40 • Number of events 7 • 24 hours following the treatment
|
22.5%
9/40 • Number of events 9 • 24 hours following the treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • 24 hours following the treatment
|
5.0%
2/40 • Number of events 2 • 24 hours following the treatment
|
|
Skin and subcutaneous tissue disorders
Pain and swelling at i.v. catheter site
|
0.00%
0/40 • 24 hours following the treatment
|
2.5%
1/40 • Number of events 1 • 24 hours following the treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place