Clinical trial

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

Name

20230610

Description

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.

Trial arms

Trial start

2023-03-01

Estimated PCD

2023-07-30

Trial end

2023-07-31

Treatment

rocuronium

Advanced intravenous injection of rocuronium before the succinylcholine injection

Arms:

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

Size

Primary endpoint

The appearance of myofibrillation

Average 45 seconds

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-07-25

1 organization

1 product

2 indications

Organization

Product

Indication

Indication