Clinical trial NCT04581395: The Effect of Pretreatment With Roc on Succinylcholine Myalgias
Official title: The Effect of Precurarization With Rocuronium on the Incidence and Severity of Succinylcholine-Induced Fasciculations and Myalgias in a High Volume ERCP Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myalgia
Keywords: Myalgias
Fasciculations
succinylcholine
rocuronium
pretreatment
precurarization
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Myalgias Perceived at 3 Hours
timeFrame: 3 hours post succinylcholine administration
measure: Myalgias at 24 Hours Post Succinylcholine Administration.
timeFrame: 24 hours post succinylcholine administration
measure: Pain Scores
timeFrame: 3 hours post succinylcholine administration
measure: Pain Scores
timeFrame: 24 hours post succinylcholine administration.
Secondary outcomes:
measure: Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration
timeFrame: immediately following succinylcholine administration up to 2 minutes
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Leighan Bye, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.
citation: Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.
citation: Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.
citation: Martin R, Carrier J, Pirlet M, Claprood Y, Tetrault JP. Rocuronium is the best non-depolarizing relaxant to prevent succinylcholine fasciculations and myalgia. Can J Anaesth. 1998 Jun;45(6):521-5. doi: 10.1007/BF03012701.
citation: Schreiber JU, Lysakowski C, Fuchs-Buder T, Tramer MR. Prevention of succinylcholine-induced fasciculation and myalgia: a meta-analysis of randomized trials. Anesthesiology. 2005 Oct;103(4):877-84. doi: 10.1097/00000542-200510000-00027.
citation: Abbas N, Tariq S, Khan AW, Murtaza G, Naqvi N, Khanzada A. To asses the effects of rocuronium pretreatment on succinylcholine induced fasciculations and postoperative myalgias. J Pak Med Assoc. 2009 Dec;59(12):847-50.
citation: Kim KN, Kim KS, Choi HI, Jeong JS, Lee HJ. Optimal precurarizing dose of rocuronium to decrease fasciculation and myalgia following succinylcholine administration. Korean J Anesthesiol. 2014 Jun;66(6):451-6. doi: 10.4097/kjae.2014.66.6.451. Epub 2014 Jun 26.