The Effect of Pretreatment With Roc on Succinylcholine Myalgias

July 6, 2023 updated by: Leighan S. Bye, MD, PhD, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Not pretreated
Succinylcholine administration with no Rocuronium pre-treatment
Other: non-pretreated Succinylcholine
no pretreatment
Other Names:
  • Control group
Active Comparator: Pre-treated 1 minute before succinylcholine administration
Succinylcholine administration 1 minute following Rocuronium pre-treatment
Drug: succinylcholine 1 minute after rocuronium 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
Other Names:
  • rocuronium pretreatment 1 minute before succinylcholine administration
Active Comparator: Pre-treated 2 minutes before succinylcholine administratjion
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
Drug: succinylcholine 2 minutes following rocuronium 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 Names:
  • rocuronium pretreatment 2 minutes before succinylcholine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence and severity of myalgias
Time Frame: 3 hours post succinylcholine administration
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
Time Frame: 24 hours post succinylcholine administration
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
Time Frame: immediately 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Leighan Bye, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

April 25, 2023

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912284619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myalgia

Clinical Trials on non-pretreated Succinylcholine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe