Trial Outcomes & Findings for Fade Upon TOF Stimulation Induced by Succinylcholine (NCT NCT02425449)
NCT ID: NCT02425449
Last Updated: 2018-01-02
Results Overview
We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.
COMPLETED
PHASE4
19 participants
for the duration of the effect of succinylcholine generally expected to be 6-10 minutes
2018-01-02
Participant Flow
Participant milestones
| Measure |
Arm 1
0.1 mg/kg of succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 2
0.15 mg/kg of succinycholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 3
0.2 mg/kg of succinylcholne arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 4
0.25 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 5
0.3 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
4
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
0
|
4
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fade Upon TOF Stimulation Induced by Succinylcholine
Baseline characteristics by cohort
| Measure |
Arm 1
0.1 mg/kg of succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 2
n=4 Participants
0.15 mg/kg of succinycholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 3
n=5 Participants
0.2 mg/kg of succinylcholne arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 4
n=5 Participants
0.25 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 5
n=5 Participants
0.3 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
35.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
36.2 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
36.9 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
—
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: for the duration of the effect of succinylcholine generally expected to be 6-10 minutesWe stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.
Outcome measures
| Measure |
Arm 1
0.1 mg/kg of succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 2
n=4 Participants
0.15 mg/kg of succinycholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 3
n=5 Participants
0.2 mg/kg of succinylcholne arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 4
n=5 Participants
0.25 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
Arm 5
n=5 Participants
0.3 mg/kg succinylcholine arm
Succinylcholine: will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
|
|---|---|---|---|---|---|
|
Fade on Train of Four Stimulation
|
—
|
0.85 Ratio
Standard Deviation 0.02
|
0.64 Ratio
Standard Deviation 0.04
|
0.66 Ratio
Standard Deviation 0.09
|
0.68 Ratio
Standard Deviation 0.04
|
Adverse Events
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
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