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

Primary Purpose

Fasciculation, Succinylcholine

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cisatracurium
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fasciculation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages ranged from 18 to 80. 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

Sites / Locations

  • the Affiliated Hospital of Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Age range of 18 to 44 years olds

Age range of 45 to 59 years olds

Age range of 60 to 80 years olds

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The appearance of fasciculation Yes or No
Yes or No
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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
February 26, 2023
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05760976
Brief Title
Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine
Official Title
Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciculation, Succinylcholine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Age range of 18 to 44 years olds
Arm Type
Experimental
Arm Description
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.
Arm Title
Age range of 45 to 59 years olds
Arm Type
Experimental
Arm Description
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.
Arm Title
Age range of 60 to 80 years olds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium
Intervention Description
Advanced intravenous injection of cisatracurium before the succinylcholine injection
Primary Outcome Measure Information:
Title
The appearance of fasciculation Yes or No
Description
Yes or No
Time Frame
an average of 2 minutes
Title
The levels of fasciculation
Description
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.
Time Frame
an average of 2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages ranged from 18 to 80. 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
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Zhuan, professor
Phone
+8615062791355
Email
zhangzhuancg@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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