Pain
Conditions
Keywords
Succinylcholine, Statins, myalgias, statins with succinylcholine and pain
Brief summary
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.
Interventions
DRUGSuccinylcholine
Succinylcholine will be administered pre-induction over a period of 5 seconds
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery * ASA Physical Status 1-3
Exclusion criteria
* History of liver failure * History of renal failure * History of neuromuscular disease * Increased intraocular pressure * Recent major burn * Multiple trauma * Susceptibility to or family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Myoglobin Concentration | induction, 5 minutes after administration, 20 minutes and 24 hours post operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Pain | 2 and 24 hours postoperatively | verbal 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. |
| Serum Potassium Concentration | At 5 and 20 min after succinylcholine | — |
| Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | 2 and 24 hours postoperatively | Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively |
| Duration of Succinylcholine Block | intraoperative: from succinylcholine administration | Time required to reach maximum block by succinylcholine after succinylcholine administration. |
| Fasciculation | postoperative | The 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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 | 32 |
| Total | 70 |
Baseline characteristics
| Characteristic | Statin Use Group | Non Statin Use | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 9 | 57 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 38 participants | 32 participants | 70 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 32 |
| serious Total, serious adverse events | 0 / 38 | 0 / 32 |
Outcome results
Primary
Plasma Myoglobin Concentration
Time frame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Statin Use Group | Plasma Myoglobin Concentration | Measurement time = induction (0 minute) | 46 ug/l |
| Statin Use Group | Plasma Myoglobin Concentration | Measurement time = 5 minute | 71 ug/l |
| Statin Use Group | Plasma Myoglobin Concentration | Measurement time = 20 minute (primary) | 77 ug/l |
| Statin Use Group | Plasma Myoglobin Concentration | Measurement time = 24 hour | 137 ug/l |
| Non Statin Use | Plasma Myoglobin Concentration | Measurement time = 24 hour | 95 ug/l |
| Non Statin Use | Plasma Myoglobin Concentration | Measurement time = induction (0 minute) | 39 ug/l |
| Non Statin Use | Plasma Myoglobin Concentration | Measurement time = 20 minute (primary) | 47 ug/l |
| Non Statin Use | Plasma Myoglobin Concentration | Measurement time = 5 minute | 49 ug/l |
p-value: 0.01895% CI: [1.05, 1.72]ANCOVA
Secondary
Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively
Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively
Time frame: 2 and 24 hours postoperatively
Population: Two patients in the nonstatin group had missing CK value at 2 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Statin Use Group | Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | 175 units/l |
| Non Statin Use | Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively | 78 units/l |
Secondary
Duration of Succinylcholine Block
Time required to reach maximum block by succinylcholine after succinylcholine administration.
Time frame: intraoperative: from succinylcholine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Statin Use Group | Duration of Succinylcholine Block | 4.2 minute |
| Non Statin Use | Duration of Succinylcholine Block | 4.6 minute |
Secondary
Fasciculation
The 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.
Time frame: postoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statin Use Group | Fasciculation | None | 9 participants |
| Statin Use Group | Fasciculation | Small | 6 participants |
| Statin Use Group | Fasciculation | Moderate | 10 participants |
| Statin Use Group | Fasciculation | Vigorous | 13 participants |
| Non Statin Use | Fasciculation | Vigorous | 8 participants |
| Non Statin Use | Fasciculation | None | 13 participants |
| Non Statin Use | Fasciculation | Moderate | 8 participants |
| Non Statin Use | Fasciculation | Small | 3 participants |
Secondary
Muscle Pain
verbal 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.
Time frame: 2 and 24 hours postoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statin Use Group | Muscle Pain | VRS score at 2 hour: 0 (no pain) | 34 participants |
| Statin Use Group | Muscle Pain | VRS score at 2 hour: 10-30 | 2 participants |
| Statin Use Group | Muscle Pain | VRS score at 2 hour: 40-70 | 1 participants |
| Statin Use Group | Muscle Pain | VRS score at 2 hour: 80-100 | 1 participants |
| Statin Use Group | Muscle Pain | VRS score at 24 hour: 0 (no pain) | 34 participants |
| Statin Use Group | Muscle Pain | VRS score at 24 hour: 10-30 | 2 participants |
| Statin Use Group | Muscle Pain | VRS score at 24 hour: 40-70 | 1 participants |
| Statin Use Group | Muscle Pain | VRS score at 24 hour: 80-100 | 1 participants |
| Statin Use Group | Muscle Pain | Pain score at 2 hour: 0 (no pain) | 34 participants |
| Statin Use Group | Muscle Pain | Pain score at 2 hour: 1 | 4 participants |
| Statin Use Group | Muscle Pain | Pain score at 2 hour: 2 | 0 participants |
| Statin Use Group | Muscle Pain | Pain score at 24 hour: 0 (no pain) | 34 participants |
| Statin Use Group | Muscle Pain | Pain score at 24 hour: 1 | 4 participants |
| Statin Use Group | Muscle Pain | Pain score at 24 hour: 2 | 0 participants |
| Non Statin Use | Muscle Pain | Pain score at 2 hour: 2 | 3 participants |
| Non Statin Use | Muscle Pain | VRS score at 2 hour: 0 (no pain) | 26 participants |
| Non Statin Use | Muscle Pain | VRS score at 24 hour: 80-100 | 1 participants |
| Non Statin Use | Muscle Pain | VRS score at 2 hour: 10-30 | 0 participants |
| Non Statin Use | Muscle Pain | Pain score at 24 hour: 1 | 5 participants |
| Non Statin Use | Muscle Pain | VRS score at 2 hour: 40-70 | 4 participants |
| Non Statin Use | Muscle Pain | Pain score at 2 hour: 0 (no pain) | 26 participants |
| Non Statin Use | Muscle Pain | VRS score at 2 hour: 80-100 | 2 participants |
| Non Statin Use | Muscle Pain | Pain score at 24 hour: 0 (no pain) | 25 participants |
| Non Statin Use | Muscle Pain | VRS score at 24 hour: 0 (no pain) | 25 participants |
| Non Statin Use | Muscle Pain | Pain score at 2 hour: 1 | 3 participants |
| Non Statin Use | Muscle Pain | VRS score at 24 hour: 10-30 | 4 participants |
| Non Statin Use | Muscle Pain | Pain score at 24 hour: 2 | 2 participants |
| Non Statin Use | Muscle Pain | VRS score at 24 hour: 40-70 | 2 participants |
Secondary
Serum Potassium Concentration
Time frame: At 5 and 20 min after succinylcholine
Population: Two patients in non-statin group had missing value at 20 minute.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Statin Use Group | Serum Potassium Concentration | at 5 minute | 4.2 mEq/l |
| Statin Use Group | Serum Potassium Concentration | at 20 minute | 4.0 mEq/l |
| Non Statin Use | Serum Potassium Concentration | at 5 minute | 4.2 mEq/l |
| Non Statin Use | Serum Potassium Concentration | at 20 minute | 3.9 mEq/l |