Trial Outcomes & Findings for Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT) (NCT NCT01441960)
NCT ID: NCT01441960
Last Updated: 2015-06-02
Results Overview
The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.
COMPLETED
NA
45 participants
Up to six weeks following inclusion
2015-06-02
Participant Flow
45 hospitalized patients aged 24-80 admitted for a series of ECT treatments at a frequency of 3/week were enrolled. 14 were excluded (1 received rocuronium in error, 1 received succinylcholine in error, 1 withdrew consent, 2 did not complete series of ECT, and in 9 twitch monitoring problems resulted in non-captured or disqualified data.
Patients were randomized to either succinylcholine or rocuronium during their first ECT. During each subsequent ECT ( 2 days apart) patients received a 10% higher (if insufficient paralysis) or lower dose (if sufficient or excessive paralysis) until the minimum effective dose was identified. Then the second NMBA was tested for subsequent ECTs.
Participant milestones
| Measure |
Succinylcholine First, Then Rocuronium
After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.
By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.
|
Rocuronium First , Then Succinylcholine
After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.
By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.
|
|---|---|---|
|
First Neuromuscular Blocking Agent:
STARTED
|
26
|
19
|
|
First Neuromuscular Blocking Agent:
COMPLETED
|
18
|
13
|
|
First Neuromuscular Blocking Agent:
NOT COMPLETED
|
8
|
6
|
|
Second Neuromuscular Blocking Agent
STARTED
|
18
|
13
|
|
Second Neuromuscular Blocking Agent
COMPLETED
|
18
|
13
|
|
Second Neuromuscular Blocking Agent
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Succinylcholine First, Then Rocuronium
After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.
By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.
|
Rocuronium First , Then Succinylcholine
After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.
By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.
|
|---|---|---|
|
First Neuromuscular Blocking Agent:
Technical error or incomplete ECT series
|
6
|
5
|
|
First Neuromuscular Blocking Agent:
Protocol Violation
|
1
|
1
|
|
First Neuromuscular Blocking Agent:
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)
Baseline characteristics by cohort
| Measure |
Succinylcholine and Rocuronium
n=45 Participants
All study participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Age, Continuous
|
52 Years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to six weeks following inclusionThe optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.
Outcome measures
| Measure |
NMBA: Sux
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial.
Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.
|
NMBA- Rocuronium
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
|
|---|---|---|
|
Optimal Dose of Neuromuscular Blocking Agent During ECT
|
0.85 mg.kg-1
Interval 0.77 to 0.94
|
0.41 mg.kg-1
Interval 0.36 to 0.46
|
SECONDARY outcome
Timeframe: Up to six weeks following inclusionThe investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.
Outcome measures
| Measure |
NMBA: Sux
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial.
Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.
|
NMBA- Rocuronium
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
|
|---|---|---|
|
Compound Specific Differences in Time to Recovery From Neuromuscular Blockade
|
9.7 minutes
Standard Deviation 3.5
|
19.5 minutes
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Up to six weeks following inclusionObservational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.
Outcome measures
| Measure |
NMBA: Sux
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial.
Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.
|
NMBA- Rocuronium
n=31 Participants
Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
|
|---|---|---|
|
Differences in Seizure Duration Between Compounds
|
27 Seconds
Standard Deviation 14
|
31 Seconds
Standard Deviation 11
|
Adverse Events
NMBA: Succinylcholine
NMBA: Rocuronium
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place