The Effect of Pretreatment With Roc on Succinylcholine Myalgias
Condition: Myalgia
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): non-pretreated Succinylcholine; succinylcholine 1 minute after rocuronium pretreatment; succinylcholine 2 minutes following rocuronium pretreatment
Intervention type(s): Other; Drug; Drug
Intervention description(s): no 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; 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.
Other intervention name(s): Control group; rocuronium pretreatment 1 minute before succinylcholine administration; rocuronium pretreatment 2 minutes before succinylcholine administration
Intervention MeSH terms: Rocuronium; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myalgias; Fasciculations; succinylcholine; rocuronium; pretreatment; precurarization