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

• Sponsor: Yangzhou University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05909696
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Succinylcholine; Myofibrillation	Drug: rocuronium	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: rocuronium; Advanced intravenous injection of rocuronium before the succinylcholine injection
Experimental: 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.	Drug: rocuronium; Advanced intravenous injection of rocuronium before the succinylcholine injection
Experimental: 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.	Drug: rocuronium; Advanced intravenous injection of rocuronium before the succinylcholine injection

Outcome Measures

Primary Outcome Measures

1. The appearance of myofibrillation [Average 45 seconds]

   Yes or No

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China

Sponsors and Collaborators

• Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Director, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05909696
• Other Study ID Numbers: 20230610
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rocuronium

Study Results

No Results Posted as of Jun 18, 2023