Trial Outcomes & Findings for Effect of Succinylcholine on Patients Using Statins (NCT NCT00986583)
NCT ID: NCT00986583
Last Updated: 2016-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
Results posted on
2016-10-03
Participant Flow
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least 3 months and those who had never used statins were considered to be eligible for participation. We included patients scheduled for elective surgery (October 2009 between June 2010) in this comparative, prospective, nonrandomized study.
Participant milestones
| Measure |
Statin Use Group
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
32
|
|
Overall Study
COMPLETED
|
38
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Succinylcholine on Patients Using Statins
Baseline characteristics by cohort
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds.
|
Non Statin Use
n=32 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 9 • n=5 Participants
|
57 years
STANDARD_DEVIATION 10 • n=7 Participants
|
59 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
32 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: induction, 5 minutes after administration, 20 minutes and 24 hours post operativelyOutcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=32 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Plasma Myoglobin Concentration
Measurement time = induction (0 minute)
|
46 ug/l
Interval 40.0 to 59.0
|
39 ug/l
Interval 29.0 to 49.0
|
|
Plasma Myoglobin Concentration
Measurement time = 5 minute
|
71 ug/l
Interval 47.0 to 96.0
|
49 ug/l
Interval 31.0 to 75.0
|
|
Plasma Myoglobin Concentration
Measurement time = 20 minute (primary)
|
77 ug/l
Interval 49.0 to 112.0
|
47 ug/l
Interval 35.0 to 79.0
|
|
Plasma Myoglobin Concentration
Measurement time = 24 hour
|
137 ug/l
Interval 86.0 to 342.0
|
95 ug/l
Interval 57.0 to 210.0
|
SECONDARY outcome
Timeframe: 2 and 24 hours postoperativelyverbal rating scale score and the pain score both at 2 and 24 hours postoperatively. The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable). The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain.
Outcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=32 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Muscle Pain
VRS score at 2 hour: 0 (no pain)
|
34 participants
|
26 participants
|
|
Muscle Pain
VRS score at 2 hour: 10-30
|
2 participants
|
0 participants
|
|
Muscle Pain
VRS score at 2 hour: 40-70
|
1 participants
|
4 participants
|
|
Muscle Pain
VRS score at 2 hour: 80-100
|
1 participants
|
2 participants
|
|
Muscle Pain
VRS score at 24 hour: 0 (no pain)
|
34 participants
|
25 participants
|
|
Muscle Pain
VRS score at 24 hour: 10-30
|
2 participants
|
4 participants
|
|
Muscle Pain
VRS score at 24 hour: 40-70
|
1 participants
|
2 participants
|
|
Muscle Pain
VRS score at 24 hour: 80-100
|
1 participants
|
1 participants
|
|
Muscle Pain
Pain score at 2 hour: 0 (no pain)
|
34 participants
|
26 participants
|
|
Muscle Pain
Pain score at 2 hour: 1
|
4 participants
|
3 participants
|
|
Muscle Pain
Pain score at 2 hour: 2
|
0 participants
|
3 participants
|
|
Muscle Pain
Pain score at 24 hour: 0 (no pain)
|
34 participants
|
25 participants
|
|
Muscle Pain
Pain score at 24 hour: 1
|
4 participants
|
5 participants
|
|
Muscle Pain
Pain score at 24 hour: 2
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: At 5 and 20 min after succinylcholinePopulation: Two patients in non-statin group had missing value at 20 minute.
Outcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=30 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Serum Potassium Concentration
at 5 minute
|
4.2 mEq/l
Interval 4.0 to 4.5
|
4.2 mEq/l
Interval 4.0 to 4.5
|
|
Serum Potassium Concentration
at 20 minute
|
4.0 mEq/l
Interval 3.7 to 4.3
|
3.9 mEq/l
Interval 3.7 to 4.1
|
SECONDARY outcome
Timeframe: 2 and 24 hours postoperativelyPopulation: Two patients in the nonstatin group had missing CK value at 2 hour
Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively
Outcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=30 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively
|
175 units/l
Interval 11.0 to 333.0
|
78 units/l
Interval 19.0 to 354.0
|
SECONDARY outcome
Timeframe: intraoperative: from succinylcholine administrationTime required to reach maximum block by succinylcholine after succinylcholine administration.
Outcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=32 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Duration of Succinylcholine Block
|
4.2 minute
Interval 3.0 to 6.0
|
4.6 minute
Interval 3.3 to 6.1
|
SECONDARY outcome
Timeframe: postoperativeThe fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.
Outcome measures
| Measure |
Statin Use Group
n=38 Participants
Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
Non Statin Use
n=32 Participants
Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds
|
|---|---|---|
|
Fasciculation
None
|
9 participants
|
13 participants
|
|
Fasciculation
Small
|
6 participants
|
3 participants
|
|
Fasciculation
Moderate
|
10 participants
|
8 participants
|
|
Fasciculation
Vigorous
|
13 participants
|
8 participants
|
Adverse Events
Statin Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nonstatin Users
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place