Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine

NCT05909696 | Completed

• 1 other identifier: 20230610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• The appearance of myofibrillation

  Yes or No

  Average 45 seconds

Study Arms (3)

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.

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.

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.

Drug: rocuronium

Interventions

rocuronium DRUG

Advanced intravenous injection of rocuronium before the succinylcholine injection

Age range of 18 to 44 years olds; Age range of 45 to 59 years olds; Age range of 60 to 80 years olds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages ranged from 18 to 80.
• ASA grade I-II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

Related Publications (1)

• 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. doi: 10.1186/s12871-025-03546-5. Online ahead of print.

  PMID: 41366298 DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 31, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)