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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

for the duration of the effect of succinylcholine generally expected to be 6-10 minutes

Results posted on

2018-01-02

Participant Flow

Participant milestones

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

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 minutes

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shashi Bhatt, MD

The University of Toledo

Phone: 419-383-3556

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place