Myalgia
Conditions
Keywords
Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization
Brief summary
Succinylcholine is a medication (depolarizing muscle relaxant) that is used as part of an anesthetic (going to sleep for surgery). This medication can cause significant muscle soreness. Rocuronium is a medication (non-depolarizing muscle relaxant) that some anesthesia providers believe may reduce muscle soreness caused by succinylcholine if given prior, but this has been controversial. Some anesthesiologists pretreat patients with rocuronium before giving patients succinylcholine, and some do not. The purpose of this study is to examine the effect of pretreatment with rocuronium on muscle soreness associated with succinylcholine administration.
Detailed description
After IRB approval from Indiana University Hospital and with written and verbal informed consent from each patient, 300 ASA I, II and III outpatients scheduled for elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia will be enrolled in this randomized-controlled study. The participants and the study personnel performing post-op assessments will be blinded. Anesthesia providers cannot be blinded during this study since anesthesia providers will be required to draw up the study drugs as well as managing the wait time between rocuronium and succinylcholine. Patients are assigned to one of three groups (n = 100 each group). Each participant will undergo a standard IV induction of anesthesia (Lidocaine 1mg/kg, propofol 1-2 mg/kg titrated to effect, and succinylcholine (administered as indicated by study group assignment). Study group details are as follows: Group 1 (Control) to receive no rocuronium pretreatment and 1 mg/kg of succinylcholine. Groups 2 and 3 to receive 0.05 mg/kg up to 5 mg of rocuronium; patients ranged from 50-120 kg. In Group 2, succinylcholine administration will occur at 1.0 mg/kg at t = 1 minute after pretreatment with rocuronium. In Group 3, succinylcholine will be administered (1.0 mg/kg) at t = 2 minutes after pretreatment. The Succinylcholine-induced fasciculations will be noted on study assessment data sheet as either present or absent. . Myalgia assessment is to occur post-succinylcholine administration at t =3 hours and t = 24 hours and will be rated as described below. Myalgia assessment: Participants will by queried at the above time points about muscle pain and scored based on their answers as follows. 0 - no pain /no muscle stiffness 1. \- mild muscle pain and/or stiffness at 1 or more sites that does not limit daily activity 2. \- Moderate muscle pain and/or stiffness at 1 or more sites that does not limit daily activity 3. \- Moderate generalized muscle pain and/or stiffness limiting daily activity 4. \- Severe muscle pain and/or stiffness at 1 or more sites limiting movement and preventing daily activity
Interventions
OTHERnon-pretreated Succinylcholine
no pretreatment
DRUGsuccinylcholine 1 minute after rocuronium pretreatment
0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
DRUGsuccinylcholine 2 minutes following rocuronium pretreatment
0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Randomization will be performed using Research Randomizer in blocks of 30. The primary investigator will inform the person doing the case as to what group the participants are randomized. Both the participants and the research staff doing assessments will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia * Have been informed of the nature of the study and informed consent has been obtained
Exclusion criteria
* Patients will be excluded if they have chronic pain requiring daily opioid use greater than 30 mg PO morphine equivalent. * Patients will also be excluded if their comorbid medical conditions require a true rapid sequence induction as precurarization with rocuronium increases the time to intubation which is undesirable in a patient who is at high risk for aspiration. * Patients taking muscle relaxants at home for spasticity. * Patients under the age of 18 years old. * Any contraindication for using succinylcholine or rocuronium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myalgias Perceived at 3 Hours | 3 hours post succinylcholine administration | The data are reported as pain (scores 1-4) vs. no pain (score 0). |
| Myalgias at 24 Hours Post Succinylcholine Administration. | 24 hours post succinylcholine administration | The presence of myalgias referencing a severity scale from 0 (no muscle pain), 1 (mild muscle pain), 2(moderate muscle pain), 3 (Moderate muscle pain) and 4 (Severe muscle pain). The data are reported as pain (scores 1-4) vs. no pain (score 0) |
| Pain Scores | 3 hours post succinylcholine administration | 0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration | immediately following succinylcholine administration up to 2 minutes | Observed presence or absence of muscle fasciculation following succinylcholine administration in subjects pretreated with rocuronium 1 minute prior to succinylcholine administration or 2 minutes prior to succinylcholine administration compared to the control group not pretreated with rocuronium. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Not Pretreated Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment | 96 |
| Pre-treated 1 Minute Before Succinylcholine Administration Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment | 96 |
| Pre-treated 2 Minutes Before Succinylcholine Administratjion Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment. | 98 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | Not Pretreated | Pre-treated 1 Minute Before Succinylcholine Administration | Pre-treated 2 Minutes Before Succinylcholine Administratjion | Total |
|---|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 15 | 62 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 16 | 60 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 50 Participants | 55 Participants | 48 Participants | 153 Participants |
| Sex: Female, Male Male | 46 Participants | 41 Participants | 50 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Myalgias at 24 Hours Post Succinylcholine Administration.
The presence of myalgias referencing a severity scale from 0 (no muscle pain), 1 (mild muscle pain), 2(moderate muscle pain), 3 (Moderate muscle pain) and 4 (Severe muscle pain). The data are reported as pain (scores 1-4) vs. no pain (score 0)
Time frame: 24 hours post succinylcholine administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Not Pretreated With Rocuronium | Myalgias at 24 Hours Post Succinylcholine Administration. | patients experiencing no pain 24 hours post succinylcholine administrations | 64 Participants |
| Not Pretreated With Rocuronium | Myalgias at 24 Hours Post Succinylcholine Administration. | Patients experiencing pain at 24 hours post succinylcholine administrations | 32 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Myalgias at 24 Hours Post Succinylcholine Administration. | patients experiencing no pain 24 hours post succinylcholine administrations | 78 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Myalgias at 24 Hours Post Succinylcholine Administration. | Patients experiencing pain at 24 hours post succinylcholine administrations | 18 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Myalgias at 24 Hours Post Succinylcholine Administration. | patients experiencing no pain 24 hours post succinylcholine administrations | 80 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Myalgias at 24 Hours Post Succinylcholine Administration. | Patients experiencing pain at 24 hours post succinylcholine administrations | 18 Participants |
Primary
Myalgias Perceived at 3 Hours
The data are reported as pain (scores 1-4) vs. no pain (score 0).
Time frame: 3 hours post succinylcholine administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Not Pretreated With Rocuronium | Myalgias Perceived at 3 Hours | Patients who described having pain 3 hours post succinylcholine | 15 Participants |
| Not Pretreated With Rocuronium | Myalgias Perceived at 3 Hours | Patients with no pain 3 hours post succinylcholine | 81 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Myalgias Perceived at 3 Hours | Patients who described having pain 3 hours post succinylcholine | 13 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Myalgias Perceived at 3 Hours | Patients with no pain 3 hours post succinylcholine | 83 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Myalgias Perceived at 3 Hours | Patients with no pain 3 hours post succinylcholine | 83 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Myalgias Perceived at 3 Hours | Patients who described having pain 3 hours post succinylcholine | 15 Participants |
Primary
Pain Scores
0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.
Time frame: 3 hours post succinylcholine administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Not Pretreated With Rocuronium | Pain Scores | Pain score = 3 | 1 Participants |
| Not Pretreated With Rocuronium | Pain Scores | Pain score = 4 | 0 Participants |
| Not Pretreated With Rocuronium | Pain Scores | Pain score = 2 | 4 Participants |
| Not Pretreated With Rocuronium | Pain Scores | Pain score =0 | 81 Participants |
| Not Pretreated With Rocuronium | Pain Scores | Pain score = 1 | 10 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | Pain score = 3 | 0 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | Pain score = 2 | 1 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | Pain score =0 | 83 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | Pain score = 4 | 0 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | Pain score = 1 | 12 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | Pain score = 4 | 1 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | Pain score = 2 | 2 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | Pain score = 1 | 12 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | Pain score =0 | 83 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | Pain score = 3 | 0 Participants |
Primary
Pain Scores
0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.
Time frame: 24 hours post succinylcholine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Not Pretreated With Rocuronium | Pain Scores | 24 pain score =3 | 4 Participants |
| Not Pretreated With Rocuronium | Pain Scores | 24 hour pain score=2 | 7 Participants |
| Not Pretreated With Rocuronium | Pain Scores | 24 hour pain scores = 0 | 64 Participants |
| Not Pretreated With Rocuronium | Pain Scores | 24 hour pain scores=1 | 20 Participants |
| Not Pretreated With Rocuronium | Pain Scores | 24 pain score=4 | 1 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | 24 hour pain score=2 | 8 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | 24 hour pain scores = 0 | 78 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | 24 hour pain scores=1 | 9 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | 24 pain score =3 | 1 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pain Scores | 24 pain score=4 | 0 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | 24 pain score=4 | 1 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | 24 pain score =3 | 1 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | 24 hour pain scores = 0 | 80 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | 24 hour pain score=2 | 0 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Pain Scores | 24 hour pain scores=1 | 16 Participants |
Secondary
Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration
Observed presence or absence of muscle fasciculation following succinylcholine administration in subjects pretreated with rocuronium 1 minute prior to succinylcholine administration or 2 minutes prior to succinylcholine administration compared to the control group not pretreated with rocuronium.
Time frame: immediately following succinylcholine administration up to 2 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Not Pretreated With Rocuronium | Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration | 75 Participants |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration | 20 Participants |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration | 13 Participants |