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Completed

NCT Number: NCT04581395

The Effect of Pretreatment With Roc on Succinylcholine Myalgias

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

indiana University

Indianapolis, Indiana, 46202, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-pretreated Succinylcholine

Other

no pretreatment

Other names: Control group

succinylcholine 1 minute after rocuronium pretreatment

Drug

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

Other names: rocuronium pretreatment 1 minute before succinylcholine administration

succinylcholine 2 minutes following rocuronium pretreatment

Drug

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 names: rocuronium pretreatment 2 minutes before succinylcholine administration

Primary outcomes

  1. Myalgias Perceived at 3 Hours

    Time frame: 3 hours post succinylcholine administration

    The data are reported as pain (scores 1-4) vs. no pain (score 0).

  2. Myalgias at 24 Hours Post Succinylcholine Administration.

    Time frame: 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)

  3. Pain Scores

    Time frame: 3 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.

  4. Pain Scores

    Time frame: 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 outcomes

  1. Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2020
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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