Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Study Overview

• Status: Completed
• Conditions: Fasciculation
• Intervention / Treatment: Drug: Cisatracurium

Detailed Description

Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
• 20 - 65 years old
• without acid-base imbalance and electrolyte disturbance
• with normal hepatic and renal function

Exclusion Criteria:

• Patients with known hyperkalemia
• Patients with increased intraocular pressure
• Patients with increased intracranial pressure
• Patients with symptoms of gastroesophageal reflux
• Patients with anticipated airway difficulties
• Patients with malignant fever
• Patients with neuromuscular disease
• Patients with burn or crush injuries
• Patients with taking drugs known to alter the action of neuromuscular blockers
• Patients with with a body mass index exceeding 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cisatracurium 0.005 mg/kg; The group received pretreatment of cisatracurium 0.005 mg/kg.	Drug: Cisatracurium; Different doses of cisatracurium pretreatment; Other Names: Dose
Experimental: Cisatracurium 0.01 mg/kg; The group received pretreatment of cisatracurium 0.01 mg/kg	Drug: Cisatracurium; Different doses of cisatracurium pretreatment; Other Names: Dose
Experimental: Cisatracurium 0.02 mg/kg; The group received pretreatment of cisatracurium 0.02 mg/kg	Drug: Cisatracurium; Different doses of cisatracurium pretreatment; Other Names: Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The presence of fasciculations	After the injection of succinylcholine for 1.5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Side effects of the pretreatment of cisatracurium	At the time of three minutes after the pretreatment of cisatracurium
The time to maximal depression of twitch	From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The extent to maximal depression of twitch	From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The time for twitch recovery to 20% of its control value	From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
The grades of endotracheal intubation	At intubating time
The changes of serum potassium	After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
Myalgia at 24 hours postoperatively	At 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Yangzhou No.1 People's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Cisatracurium; Myalgia; Fasciculation; Succinylcholine
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Neuromuscular Manifestations; Myalgia; Fasciculation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Cisatracurium
• Other Study ID Numbers: YZYY-610