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

NCT ID: NCT05909696

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Age range of 18 to 44 years olds

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.

Group Type: EXPERIMENTAL

rocuronium

Intervention Type: DRUG

Advanced intravenous injection of rocuronium before the succinylcholine injection

Age range of 45 to 59 years olds

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.

Group Type: EXPERIMENTAL

rocuronium

Intervention Type: DRUG

Advanced intravenous injection of rocuronium before the succinylcholine injection

Age range of 60 to 80 years olds

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.

Group Type: EXPERIMENTAL

rocuronium

Intervention Type: DRUG

Advanced intravenous injection of rocuronium before the succinylcholine injection

Interventions

rocuronium

Advanced intravenous injection of rocuronium before the succinylcholine injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ages ranged from 18 to 80.

2. ASA grade I-II

Exclusion Criteria

1. Possible airway difficulties,

2. allergies or contraindications to rocuronium and succincholine ，

3. cardiac insufficiency,

4. hepatic or renal dysfunction,

5. neuromuscular disease,

6. surgery lasting more than 2 hours,

7. taking any known drug that has interaction with neuromuscular blockers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20230610

Identifier Type: -

Identifier Source: org_study_id