The Effect of Pretreatment With Roc on Succinylcholine Myalgias

Study Overview
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Brief Summary
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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
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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 - mild muscle pain and/or stiffness at 1 or more sites that does not limit daily activity - Moderate muscle pain and/or stiffness at 1 or more sites that does not limit daily activity - Moderate generalized muscle pain and/or stiffness limiting daily activity - Severe muscle pain and/or stiffness at 1 or more sites limiting movement and preventing daily activity

Official Title
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The Effect of Precurarization With Rocuronium on the Incidence and Severity of Succinylcholine-Induced Fasciculations and Myalgias in a High Volume ERCP Center

Conditions
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Myalgia

Intervention / Treatment
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* Other: non-pretreated Succinylcholine
* Drug: succinylcholine 1 minute after rocuronium pretreatment
* Drug: succinylcholine 2 minutes following rocuronium pretreatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Not pretreated<br>Succinylcholine administration with no Rocuronium pre-treatment | Other: non-pretreated Succinylcholine<br>* no pretreatment<br>* Other names: Control group;|
| Active Comparator: Pre-treated 1 minute before succinylcholine administration<br>Succinylcholine administration 1 minute following Rocuronium pre-treatment | Drug: succinylcholine 1 minute after rocuronium pretreatment<br>* 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<br>* Other names: rocuronium pretreatment 1 minute before succinylcholine administration;|
| Active Comparator: Pre-treated 2 minutes before succinylcholine administratjion<br>Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment | Drug: succinylcholine 2 minutes following rocuronium pretreatment<br>* 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.<br>* Other names: rocuronium pretreatment 2 minutes before succinylcholine administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and severity of myalgias | Prior to leaving the hospital the participant will be asked about the presence of myalgias referencing a severity scale from 0 (no muscle pain) to 4 debilitating muscle pain. | 3 hours post succinylcholine administration | 
| Presence and severity of myalgias | The following day the participant will be asked about the presence and severity of muscle pain using the same scale mentioned above and described in detail in the study design section. This interaction with the participant will likely occur over the telephone as ERCP is usually an outpatient procedure. | 24 hours post succinylcholine administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of muscle fasciculation following succinylcholine administration | Succinylcholine administration produces uncoordinated muscle movement called fasciculation. The investigators are interested in recording whether pretreatment with rocuronium prevents fasciculation and whether fasciculation is correlated with the presence of myalgias. | immediately following succinylcholine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization