SuccinylcholineNCT05909696
Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine
A study testing rocuronium in people with Succinylcholine and Myofibrillation, run by Yangzhou University at 1 site in China.
Trial summary
Succinylcholine is an important component of rapid sequential induction of general anesthesia because of its rapid onset and short duration of action. However, myofibrillation is a common complication after succinylcholine injection and may lead to persistent postoperative myalgia, increased intraocular, intragastric… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Succinylcholine, Myofibrillation
- What is being tested?
- rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ranged from 18 to 80.
- ASA grade I-II
Who cannot join
- Possible airway difficulties,
- allergies or contraindications to rocuronium and succincholine ，
- cardiac insufficiency,
- hepatic or renal dysfunction,
- neuromuscular disease,
- surgery lasting more than 2 hours,
- taking any known drug that has interaction with neuromuscular blockers.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
Succinylcholine is an important component of rapid sequential induction of general anesthesia because of its rapid onset and short duration of action. However, myofibrillation is a common complication after succinylcholine injection and may lead to persistent postoperative myalgia, increased intraocular, intragastric and intracranial pressure in patients. Increased risk of peri-induction and postoperative patient discomfort. The effectiveness of rocuronium bromide pretreatment in reducing succinylcholine-induced myalgias has been demonstrated in several recent studies. However, the half effective amount of rocuronium pretreatment for small doses is not well known. Therefore, this study applied the Dixon sequential method to investigate the ED50 of preemptive intravenous rocuronium bromide for the prevention of succinylcholine-induced myofibrillation and to investigate the effect of age factor on the ED50 of rocuronium bromide for the prevention of succinylcholine-induced myofibrillation to provide a reference for the rational clinical selection of rocuronium bromide dose.
- Conditions
- Succinylcholine, Myofibrillation
- Being tested
- rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuroniumDrug
Advanced intravenous injection of rocuronium before the succinylcholine injection
| Study group | Role | What they receive |
|---|---|---|
| Age range of 18 to 44 years olds | Experimental | Age range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. Receives: Drug: rocuronium |
| Age range of 45 to 59 years olds | Experimental | Age range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. Receives: Drug: rocuronium |
| Age range of 60 to 80 years olds | Experimental | Age range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. Receives: Drug: rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The appearance of myofibrillation
Yes or No
Measured: Average 45 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuccinylcholineStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909696
- Sponsor's protocol ID
- 20230610
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tian S, Chen C, Wang S, Feng S, Wang M, Liu X, Bao T, Zhang Z. Median effective dose of rocuronium for the prevention of succinylcholine-induced fasciculation: an age-stratified study. BMC Anesthesiol. 2025 Dec 10;26(1):35. doi: 10.1186/s12871-025-03546-5.
PubMed 41366298
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine
- ClinicalTrials.gov ID
- NCT05909696
- Acronym / sponsor ID
- 20230610
- Conditions
- Succinylcholine, Myofibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Succinylcholine is an important component of rapid sequential induction of general anesthesia because of its rapid onset and short duration of action. However, myofibrillation is a common complication after succinylcholine injection and may lead to persistent postoperative myalgia, increased intraocular, intragastric and intracranial pressure in patients. Increased risk of peri-induction and postoperative patient discomfort. The effectiveness of rocuronium bromide pretreatment in reducing succinylcholine-induced myalgias has been demonstrated in several recent studies. However, the half effective amount of rocuronium pretreatment for small doses is not well known. Therefore, this study applied the Dixon sequential method to investigate the ED50 of preemptive intravenous rocuronium bromide for the prevention of succinylcholine-induced myofibrillation and to investigate the effect of age factor on the ED50 of rocuronium bromide for the prevention of succinylcholine-induced myofibrillation to provide a reference for the rational clinical selection of rocuronium bromide dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age range of 18 to 44 years olds | Experimental | Drug: rocuroniumAge range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. |
| Age range of 45 to 59 years olds | Experimental | Drug: rocuroniumAge range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. |
| Age range of 60 to 80 years olds | Experimental | Drug: rocuroniumAge range of 18 to 44 years olds The initial dose of rocuronium for pre-injection was set at 0.04mg/kg according to previous literature and preliminary test results. The dose of rocuronium was according to the patients' myofibrillation level. If there is no myofibrillation (negative reaction), the dose of rocuronium in the next patient will be reduced until the patient has myofibrillation. If there is myofibrillation (positive reaction), the dose of rocuronium will be increased in the next patient until the patient is no fibrillation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages ranged from 18 to 80.
- ASA grade I-II
Key exclusion criteria (7 listed)
- Possible airway difficulties,
- allergies or contraindications to rocuronium and succincholine ，
- cardiac insufficiency,
- hepatic or renal dysfunction,
- neuromuscular disease,
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 |
|---|---|---|
| rocuroniumAdvanced intravenous injection of rocuronium before the succinylcholine injection | Drug | Age range of 18 to 44 years olds, Age range of 45 to 59 years olds, Age range of 60 to 80 years olds |
Primary outcome
The appearance of myofibrillation
Time frame: Average 45 seconds
Yes or No
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 41366298Tian S, Chen C, Wang S, Feng S, Wang M, Liu X, Bao T, Zhang Z. Median effective dose of rocuronium for the prevention of succinylcholine-induced fasciculation: an age-stratified study. BMC Anesthesiol. 2025 Dec 10;26(1):35. doi: 10.1186/s12871-025-03546-5.
- Individual participant dataSharing planned: Yes
Related trials for Succinylcholine
Not yet recruitingPhase 4
REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring
Airway Management, Endotracheal Intubation
RecruitingPhase 4
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
Anesthesia
Not yet recruiting
Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy
Anesthesia, Bronchoscopy
Recruiting
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Kidney Failure, Acute, Myopathy; Drugs
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rocuronium in people with Succinylcholine and Myofibrillation, run by Yangzhou University at 1 site in China.
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 7 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 9 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The appearance of myofibrillation (time frame: Average 45 seconds). 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 NCT05909696, which also lists 1 linked publication.
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 9 Aug 2024.