The Effect of Pretreatment With Roc on Succinylcholine Myalgias

NCT04581395 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1912284619
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Myalgia

Keywords

Myalgias; Fasciculations; succinylcholine; rocuronium; pretreatment; precurarization

Outcome Measures

Primary Outcomes (4)

• Myalgias Perceived at 3 Hours

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

  3 hours post succinylcholine administration

• Myalgias at 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)

  24 hours post succinylcholine administration

• Pain Scores

  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.

  3 hours post succinylcholine administration

• Pain Scores

  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.

  24 hours post succinylcholine administration.

Secondary Outcomes (1)

• Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration

  immediately following succinylcholine administration up to 2 minutes

Study Arms (3)

Not pretreated

OTHER

Succinylcholine administration with no Rocuronium pre-treatment

Other: non-pretreated Succinylcholine

Pre-treated 1 minute before succinylcholine administration

ACTIVE COMPARATOR

Succinylcholine administration 1 minute following Rocuronium pre-treatment

Drug: succinylcholine 1 minute after rocuronium pretreatment

Pre-treated 2 minutes before succinylcholine administratjion

ACTIVE COMPARATOR

Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment

Drug: succinylcholine 2 minutes following rocuronium pretreatment

Interventions

non-pretreated Succinylcholine OTHER

no pretreatment

Also known as: Control group

Not pretreated

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

Also known as: rocuronium pretreatment 1 minute before succinylcholine administration

Pre-treated 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.

Also known as: rocuronium pretreatment 2 minutes before succinylcholine administration

Pre-treated 2 minutes before succinylcholine administratjion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia
• Have been informed of the nature of the study and informed consent has been obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (9)

• Martyn J, Durieux ME. Succinylcholine: new insights into mechanisms of action of an old drug. Anesthesiology. 2006 Apr;104(4):633-4. doi: 10.1097/00000542-200604000-00004. No abstract available.

  PMID: 16571955 BACKGROUND

• Wong SF, Chung F. Succinylcholine-associated postoperative myalgia. Anaesthesia. 2000 Feb;55(2):144-52. doi: 10.1046/j.1365-2044.2000.055002144.x.

  PMID: 10651675 BACKGROUND

• Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.

  BACKGROUND

• Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.

  PMID: 2139549 BACKGROUND

• Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.

  PMID: 9429043 BACKGROUND

• Martin R, Carrier J, Pirlet M, Claprood Y, Tetrault JP. Rocuronium is the best non-depolarizing relaxant to prevent succinylcholine fasciculations and myalgia. Can J Anaesth. 1998 Jun;45(6):521-5. doi: 10.1007/BF03012701.

  PMID: 9669004 BACKGROUND

• Schreiber JU, Lysakowski C, Fuchs-Buder T, Tramer MR. Prevention of succinylcholine-induced fasciculation and myalgia: a meta-analysis of randomized trials. Anesthesiology. 2005 Oct;103(4):877-84. doi: 10.1097/00000542-200510000-00027.

  PMID: 16192781 BACKGROUND

• Abbas N, Tariq S, Khan AW, Murtaza G, Naqvi N, Khanzada A. To asses the effects of rocuronium pretreatment on succinylcholine induced fasciculations and postoperative myalgias. J Pak Med Assoc. 2009 Dec;59(12):847-50.

  PMID: 20201179 BACKGROUND

• Kim KN, Kim KS, Choi HI, Jeong JS, Lee HJ. Optimal precurarizing dose of rocuronium to decrease fasciculation and myalgia following succinylcholine administration. Korean J Anesthesiol. 2014 Jun;66(6):451-6. doi: 10.4097/kjae.2014.66.6.451. Epub 2014 Jun 26.

  PMID: 25006369 BACKGROUND

MeSH Terms

Conditions

Myalgia; Fasciculation

Interventions

Control Groups; Succinylcholine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Results Point of Contact

• Title: Dr. Leighan Bye, Assistant Professor of Clinical Anesthesia
• Organization: IU school of Medicine, Department of Anesthesiology

lbye@iu.edu

317-274-0275

Study Officials

• Leighan Bye, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed using Research Randomizer in blocks of 30. The primary investigator will inform the person doing the case as to what group the participants are randomized. Both the participants and the research staff doing assessments will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of clinical Anesthesiology

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 9, 2020
• Study Start: October 2, 2020
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: August 21, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)