The Effect of Pretreatment With Roc on Succinylcholine Myalgias

NCT ID: NCT04581395

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2023-04-25

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.

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

Conditions

Myalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Not pretreated

Succinylcholine administration with no Rocuronium pre-treatment

Group Type: OTHER

non-pretreated Succinylcholine

Intervention Type: OTHER

no pretreatment

Pre-treated 1 minute before succinylcholine administration

Succinylcholine administration 1 minute following Rocuronium pre-treatment

Group Type: ACTIVE_COMPARATOR

succinylcholine 1 minute after rocuronium pretreatment

Intervention Type: 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

Pre-treated 2 minutes before succinylcholine administratjion

Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment

Group Type: ACTIVE_COMPARATOR

succinylcholine 2 minutes following rocuronium pretreatment

Intervention Type: 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.

Interventions

non-pretreated Succinylcholine

no pretreatment

Intervention Type: OTHER

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Control group; rocuronium pretreatment 1 minute before succinylcholine administration; rocuronium pretreatment 2 minutes before succinylcholine administration

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Leighan S. Bye, MD, PhD

Assistant Professor of clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leighan Bye, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

indiana University

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16571955 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10651675 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

PMID: 2139549 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 9429043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9669004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16192781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20201179 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25006369 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1912284619

Identifier Type: -

Identifier Source: org_study_id