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

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.

Study Overview

• Status: Recruiting
• Conditions: Fasciculation; Succinylcholine
• Intervention / Treatment: Drug: Cisatracurium

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225000
      • Recruiting
      • the Affiliated Hospital of Yangzhou University
      • Contact: Zhang Zhuan, professor; Phone Number: +8615062791355; Email: zhangzhuancg@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age range of 18 to 44 years olds; 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; Advanced intravenous injection of cisatracurium before the succinylcholine injection
Experimental: Age range of 45 to 59 years olds; 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; Advanced intravenous injection of cisatracurium before the succinylcholine injection
Experimental: Age range of 60 to 80 years olds; 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; Advanced intravenous injection of cisatracurium before the succinylcholine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Fasciculation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Cisatracurium
• Other Study ID Numbers: 20230226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No