A Phase 3 interventional study of non-pretreated Succinylcholine and succinylcholine 1 minute after rocuronium pretreatment in Myalgia, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Indiana University · Phase 3, Interventional, and Treatment
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.
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
282 studies on the registry are indexed under Myalgia; 43 are open to participants now.
This study's enrollment of 300 is above the median of 44 across 241 interventional studies indexed under Myalgia.
Browse Myalgia studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Exclusion Criteria:
Succinylcholine administration with no Rocuronium pre-treatment
Other: non-pretreated Succinylcholine
Succinylcholine administration 1 minute following Rocuronium pre-treatment
Drug: succinylcholine 1 minute after rocuronium pretreatment
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
Drug: succinylcholine 2 minutes following rocuronium pretreatment
no pretreatment
Also known as: Control group
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
Also known as: rocuronium pretreatment 1 minute before succinylcholine administration
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.
Also known as: rocuronium pretreatment 2 minutes before succinylcholine administration
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
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
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
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.
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
| Milestone | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| Started | 100 | 100 | 100 |
| Completed | 96 | 96 | 98 |
| Not completed | 4 | 4 | 2 |
| Withdrew: Protocol violation | 4 | 3 | 2 |
| Withdrew: Physician decision | 0 | 1 | 0 |
The data are reported as pain (scores 1-4) vs. no pain (score 0).
| Participants | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| Patients with no pain 3 hours post succinylcholine | 81 | 83 | 83 |
| Patients who described having pain 3 hours post succinylcholine | 15 | 13 | 15 |
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)
| Participants | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| patients experiencing no pain 24 hours post succinylcholine administrations | 64 | 78 | 80 |
| Patients experiencing pain at 24 hours post succinylcholine administrations | 32 | 18 | 18 |
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.
| Participants | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| Pain score =0 | 81 | 83 | 83 |
| Pain score = 1 | 10 | 12 | 12 |
| Pain score = 2 | 4 | 1 | 2 |
| Pain score = 3 | 1 | 0 | 0 |
| Pain score = 4 | 0 | 0 | 1 |
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.
| Participants | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| 24 hour pain scores = 0 | 64 | 78 | 80 |
| 24 hour pain scores=1 | 20 | 9 | 16 |
| 24 hour pain score=2 | 7 | 8 | 0 |
| 24 pain score =3 | 4 | 1 | 1 |
| 24 pain score=4 | 1 | 0 | 1 |
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.
| Participants | Not Pretreated With Rocuronium | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion |
|---|---|---|---|
| Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration | 75 | 20 | 13 |
Collected over 24 hours post succinylcholine administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Not Pretreated With Rocuronium | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
There is a total of 290 participants, randomized to a control arm and 2 experimental arms.
| Age, Continuous(years) | Not Pretreated | Pre-treated 1 Minute Before Succinylcholine Administration | Pre-treated 2 Minutes Before Succinylcholine Administratjion | Total |
|---|---|---|---|---|
| Mean | 60 ± 15 | 62 ± 14 | 59 ± 16 | 60 ± 15 |
| Sex: Female, Male(Participants) | Not Pretreated | Pre-treated 1 Minute Before Succinylcholine Administration | Pre-treated 2 Minutes Before Succinylcholine Administratjion | Total |
|---|---|---|---|---|
| Female | 50 | 55 | 48 | 153 |
| Male | 46 | 41 | 50 | 137 |
| Race and Ethnicity Not Collected(Participants) | Not Pretreated | Pre-treated 1 Minute Before Succinylcholine Administration | Pre-treated 2 Minutes Before Succinylcholine Administratjion | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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Indiana University