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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Not pretreated | Other | Succinylcholine administration with no Rocuronium pre-treatment |
|
| Pre-treated 1 minute before succinylcholine administration | Active Comparator | Succinylcholine administration 1 minute following Rocuronium pre-treatment |
|
| Pre-treated 2 minutes before succinylcholine administratjion | Active Comparator | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-pretreated Succinylcholine | Other | no pretreatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leighan Bye, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571955 | Background | 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. | |
| 10651675 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Not Pretreated With Rocuronium | Succinylcholine administration with no Rocuronium pre-treatment non-pretreated Succinylcholine: no pretreatment |
| FG001 | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Succinylcholine administration 1 minute following Rocuronium pre-treatment 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 |
| FG002 | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There is a total of 290 participants, randomized to a control arm and 2 experimental arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Pretreated | Succinylcholine administration with no Rocuronium pre-treatment non-pretreated Succinylcholine: no pretreatment |
| BG001 | Pre-treated 1 Minute Before Succinylcholine Administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients age is collected upon consent as part of the demographics to be used to validate cohorts variables between arms of the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Myalgias Perceived at 3 Hours | The data are reported as pain (scores 1-4) vs. no pain (score 0). | Posted | Count of Participants | Participants | No | 3 hours post succinylcholine administration |
|
24 hours post succinylcholine administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not Pretreated With Rocuronium | Succinylcholine administration with no Rocuronium pre-treatment non-pretreated Succinylcholine: no pretreatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leighan Bye, Assistant Professor of Clinical Anesthesia | IU school of Medicine, Department of Anesthesiology | 317-274-0275 | lbye@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2021 | Apr 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2022 | Apr 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D005207 | Fasciculation |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D013390 | Succinylcholine |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
| 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 |
|
|
| 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. |
|
|
| immediately following succinylcholine administration up to 2 minutes |
| Background | Hager HH, Burns B. Depolarizing Muscle Relaxants, Succinylcholine Chloride. [Update 2018 Jun13]. In StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-. |
| 2139549 | Background | Pace NL. Prevention of succinylcholine myalgias: a meta-analysis. Anesth Analg. 1990 May;70(5):477-83. doi: 10.1213/00000539-199005000-00002. |
| 9429043 | 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. |
| 9669004 | 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. |
| 16192781 | 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. |
| 20201179 | 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. |
| 25006369 | 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. |
Succinylcholine administration 1 minute following Rocuronium pre-treatment
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
| BG002 | Pre-treated 2 Minutes Before Succinylcholine Administratjion | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | sex/gender is collected at enrollment to use in demographic analysis between cohort groups. | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment 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. |
|
|
| Primary | 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) | Posted | Count of Participants | Participants | No | 24 hours post succinylcholine administration |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 3 hours post succinylcholine administration |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 24 hours post succinylcholine administration. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | No | immediately following succinylcholine administration up to 2 minutes |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Succinylcholine administration 1 minute following Rocuronium pre-treatment 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 | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment 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. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D008722 | Methods |
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| Male |
|
|
| Title | Measurements |
|---|---|
|
| Pain score = 2 |
|
| Pain score = 3 |
|
| Pain score = 4 |
|
|
| 24 hour pain score=2 |
|
| 24 pain score =3 |
|
| 24 pain score=4 |
|