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The Effect of Pretreatment With Roc on Succinylcholine Myalgias

Primary Purpose

Myalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
non-pretreated Succinylcholine
succinylcholine 1 minute after rocuronium pretreatment
succinylcholine 2 minutes following rocuronium pretreatment
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myalgia focused on measuring Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Not pretreated

Pre-treated 1 minute before succinylcholine administration

Pre-treated 2 minutes before succinylcholine administratjion

Arm Description

Succinylcholine administration with no Rocuronium pre-treatment

Succinylcholine administration 1 minute following Rocuronium pre-treatment

Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment

Outcomes

Primary Outcome Measures

Presence and severity of myalgias
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.
Presence and severity of myalgias
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.

Secondary Outcome Measures

Presence or absence of muscle fasciculation 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.

Full Information

First Posted
September 25, 2020
Last Updated
July 6, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04581395
Brief Title
The Effect of Pretreatment With Roc on Succinylcholine Myalgias
Official Title
The Effect of Precurarization With Rocuronium on the Incidence and Severity of Succinylcholine-Induced Fasciculations and Myalgias in a High Volume ERCP Center
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 - 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgia
Keywords
Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Not pretreated
Arm Type
Other
Arm Description
Succinylcholine administration with no Rocuronium pre-treatment
Arm Title
Pre-treated 1 minute before succinylcholine administration
Arm Type
Active Comparator
Arm Description
Succinylcholine administration 1 minute following Rocuronium pre-treatment
Arm Title
Pre-treated 2 minutes before succinylcholine administratjion
Arm Type
Active Comparator
Arm Description
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
Intervention Type
Other
Intervention Name(s)
non-pretreated Succinylcholine
Other Intervention Name(s)
Control group
Intervention Description
no pretreatment
Intervention Type
Drug
Intervention Name(s)
succinylcholine 1 minute after rocuronium pretreatment
Other Intervention Name(s)
rocuronium pretreatment 1 minute before succinylcholine administration
Intervention Description
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
Intervention Name(s)
succinylcholine 2 minutes following rocuronium pretreatment
Other Intervention Name(s)
rocuronium pretreatment 2 minutes before succinylcholine administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence and severity of myalgias
Description
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.
Time Frame
3 hours post succinylcholine administration
Title
Presence and severity of myalgias
Description
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.
Time Frame
24 hours post succinylcholine administration
Secondary Outcome Measure Information:
Title
Presence or absence of muscle fasciculation following succinylcholine administration
Description
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.
Time Frame
immediately following succinylcholine administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leighan Bye, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16571955
Citation
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.
Results Reference
background
PubMed Identifier
10651675
Citation
Wong SF, Chung F. Succinylcholine-associated postoperative myalgia. Anaesthesia. 2000 Feb;55(2):144-52. doi: 10.1046/j.1365-2044.2000.055002144.x.
Results Reference
background
Citation
Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.
Results Reference
background
PubMed Identifier
2139549
Citation
Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.
Results Reference
background
PubMed Identifier
9429043
Citation
Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.
Results Reference
background
PubMed Identifier
9669004
Citation
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.
Results Reference
background
PubMed Identifier
16192781
Citation
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.
Results Reference
background
PubMed Identifier
20201179
Citation
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.
Results Reference
background
PubMed Identifier
25006369
Citation
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.
Results Reference
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The Effect of Pretreatment With Roc on Succinylcholine Myalgias

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