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

NCT05760976 | Unknown

• 1 other identifier: 20230226
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fasciculation; Succinylcholine

Outcome Measures

Primary Outcomes (2)

• The appearance of fasciculation Yes or No

  Yes or No

  an average of 2 minutes

• 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

Study Arms (3)

Age range of 18 to 44 years olds

EXPERIMENTAL

The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.

Drug: Cisatracurium

Age range of 45 to 59 years olds

EXPERIMENTAL

The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.

Drug: Cisatracurium

Age range of 60 to 80 years olds

EXPERIMENTAL

The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.

Drug: Cisatracurium

Interventions

Cisatracurium DRUG

Advanced intravenous injection of cisatracurium 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 # or # level.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

RECRUITING

MeSH Terms

Conditions

Fasciculation

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: February 26, 2023
• First Posted: March 9, 2023
• Study Start: February 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

CN (1)