Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine

Fasciculation Clinical Trial

Official title:

Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760976
• Other study ID #: 20230226
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Succinylcholine is currently the only depolarizing neuromuscular blocker widely used in anesthesia induction and is the drug of choice for rapid sequential anesthesia induction. However, with succinylcholine, varying degrees of muscle fibrillation and muscle pain occur. Intravenous injection of succinylcholine caused by myomuscular fibrillation can cause increased intragastric pressure, intraocular pressure and intracranial pressure, increased serum potassium and postoperative myalgia, increased the incidence of adverse events such as needle prolapse, extravasation of injected drugs, and reduced perioperative comfort of patients. Pretreatment with cisatracurium provides limited prevention of muscular fibrillation due to succinylcholine, but the choice of dose often depends on user experience, and there have been no previous studies of age-related doses of cisatracurium for the prevention of muscular fibrillation caused by succinylcholine, and its half-effective amount (ED50) has not been established. In this study, patients treated with elective general anesthesia surgery were the subjects, and in the process of general anesthesia induction, cis-atracurium was pretreated to evaluate the degree of inhibition of muscular fibrillation caused by succinylcholine, and half of the effective dose of cis-atracurium inhibition of muscular fibrillation caused by succinylcholine was calculated by sequential method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ages ranged from 18 to 80.

2. ASA # or # level.

Exclusion Criteria:

• Allergy or contraindication to cisatracurium or succinylcholine;

• Associated with cardiovascular disease, diabetes, hyperkalemia, increased intraocular pressure, increased intracranial pressure, gastroesophageal reflux, difficult airway, malignant hyperthermia, neuromuscular disease Sick;

• Take drugs that may affect neuromuscular function before surgery

• Liver or kidney failure

• Pregnancy

Related Conditions & MeSH terms

• Fasciculation

Intervention

Drug:
• Cisatracurium
Advanced intravenous injection of cisatracurium before the succinylcholine injection

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The appearance of fasciculation Yes or No	Yes or No	an average of 2 minutes
Primary	The levels of fasciculation	Fasciculation after the administration of medications was examined and graded by an anesthesiologist using four-point Likert scale: Grade 0 = no fasciculation; Grade 1 = mild, fine fasciculations of the eyes, neck, face, or fingers, without limb movement; Grade 2 = moderate fasciculations occurring at more than two sites or obvious limb movement; and Grade 3 = vigorous or severe, sustained, and widespread fasciculations in the trunk and limbs.	an average of 2 minutes