MyalgiaPhase 3NCT04581395
The Effect of Pretreatment With Roc on Succinylcholine Myalgias
A Phase 3 study testing non-pretreated Succinylcholine, succinylcholine 1 minute after rocuronium pretreatment and succinylcholine 2 minutes following rocuronium pretreatment in people with Myalgia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myalgia
- What is being tested?
- non-pretreated Succinylcholine, succinylcholine 1 minute after rocuronium pretreatment and succinylcholine 2 minutes following rocuronium pretreatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 25 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia
- Have been informed of the nature of the study and informed consent has been obtained
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Myalgia
- Being tested
- non-pretreated Succinylcholine, succinylcholine 1 minute after rocuronium pretreatment, succinylcholine 2 minutes following rocuronium pretreatment
- Keywords
- Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization
- Medical subject headings
- Myalgia, Fasciculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pretreated SuccinylcholineOther
Also called Control group
no pretreatment
succinylcholine 1 minute after rocuronium pretreatmentDrug
Also called rocuronium pretreatment 1 minute before succinylcholine administration
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
succinylcholine 2 minutes following rocuronium pretreatmentDrug
Also called rocuronium pretreatment 2 minutes before succinylcholine administration
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.
| Study group | Role | What they receive |
|---|---|---|
| Not pretreated | Other | Succinylcholine administration with no Rocuronium pre-treatment Receives: Other: non-pretreated Succinylcholine |
| Pre-treated 1 minute before succinylcholine administration | Active comparator | Succinylcholine administration 1 minute following Rocuronium pre-treatment Receives: Drug: succinylcholine 1 minute after rocuronium pretreatment |
| Pre-treated 2 minutes before succinylcholine administratjion | Active comparator | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment Receives: Drug: succinylcholine 2 minutes following rocuronium pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myalgias Perceived at 3 Hours
The data are reported as pain (scores 1-4) vs. no pain (score 0).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 24 hours post succinylcholine administration.
Secondary outcomes (1)
Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration
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.
Measured: immediately following succinylcholine administration up to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start2 Oct 2020
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MyalgiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leighan S. Bye, MD, PhD, Indiana University
- Investigators
- Leighan Bye, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581395
- Sponsor's protocol ID
- 1912284619
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2020
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16571955Wong SF, Chung F. Succinylcholine-associated postoperative myalgia. Anaesthesia. 2000 Feb;55(2):144-52. doi: 10.1046/j.1365-2044.2000.055002144.x.
PubMed 10651675Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.
Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.
PubMed 2139549Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.
PubMed 9429043Martin 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.
PubMed 9669004Schreiber 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.
PubMed 16192781Abbas 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.
PubMed 20201179Kim 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.
PubMed 25006369
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04581395
- Acronym / sponsor ID
- 1912284619
- Conditions
- Myalgia
- Keywords
- Myalgias, Fasciculations, succinylcholine, rocuronium, pretreatment, precurarization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Not pretreated | Other | Other: non-pretreated SuccinylcholineSuccinylcholine administration with no Rocuronium pre-treatment |
| Pre-treated 1 minute before succinylcholine administration | Active comparator | Drug: succinylcholine 1 minute after rocuronium pretreatmentSuccinylcholine administration 1 minute following Rocuronium pre-treatment |
| Pre-treated 2 minutes before succinylcholine administratjion | Active comparator | Drug: succinylcholine 2 minutes following rocuronium pretreatmentSuccinylcholine administratjion 2 minutes following Rocuronium pre-treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia
- Have been informed of the nature of the study and informed consent has been obtained
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-pretreated SuccinylcholineAlso: Control groupno pretreatment | Other | Not pretreated |
| succinylcholine 1 minute after rocuronium pretreatmentAlso: rocuronium pretreatment 1 minute before succinylcholine administration0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment | Drug | Pre-treated 1 minute before succinylcholine administration |
| succinylcholine 2 minutes following rocuronium pretreatmentAlso: rocuronium pretreatment 2 minutes before succinylcholine administration0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment. | Drug | Pre-treated 2 minutes before succinylcholine administratjion |
Primary outcome
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).
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)
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.
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.
1 secondary outcome
Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration
Time frame: immediately following succinylcholine administration up to 2 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16571955Martyn 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.
- Background: PubMed 10651675Wong SF, Chung F. Succinylcholine-associated postoperative myalgia. Anaesthesia. 2000 Feb;55(2):144-52. doi: 10.1046/j.1365-2044.2000.055002144.x.
- BackgroundHager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.
- Background: PubMed 2139549Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002.
- Background: PubMed 9429043Motamed C, Choquette R, Donati F. Rocuronium prevents succinylcholine-induced fasciculations. Can J Anaesth. 1997 Dec;44(12):1262-8. doi: 10.1007/BF03012773.
- Background: PubMed 9669004Martin 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.
- Background: PubMed 16192781Schreiber 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.
- Background: PubMed 20201179Abbas 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.
- Background: PubMed 25006369Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leighan Bye, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing non-pretreated Succinylcholine, succinylcholine 1 minute after rocuronium pretreatment and succinylcholine 2 minutes following rocuronium pretreatment in people with Myalgia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myalgias Perceived at 3 Hours (time frame: 3 hours post succinylcholine administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581395, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.