The Effect of Pretreatment With Roc on Succinylcholine Myalgias

Phase 3

Completed

Conditions: Myalgia

Interventions: Other: non-pretreated Succinylcholine
Drug: succinylcholine 2 minutes following rocuronium pretreatment
Drug: succinylcholine 1 minute after rocuronium pretreatment

Registration Number: NCT04581395

Lead Sponsor: Indiana University

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Not pretreated	non-pretreated Succinylcholine	Succinylcholine administration with no Rocuronium pre-treatment
Pre-treated 2 minutes before succinylcholine administratjion	succinylcholine 2 minutes following rocuronium pretreatment	Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
Pre-treated 1 minute before succinylcholine administration	succinylcholine 1 minute after rocuronium pretreatment	Succinylcholine administration 1 minute following Rocuronium pre-treatment

Primary Outcome Measures

Name	Time	Method
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)
Myalgias Perceived at 3 Hours	3 hours post succinylcholine administration	The data are reported as pain (scores 1-4) vs. no pain (score 0).
Pain Scores	24 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 Outcome Measures

Name	Time	Method
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.