Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

NCT ID: NCT02481193

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

Brief Summary

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

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.

Conditions

Fasciculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Cisatracurium 0.005 mg/kg

The group received pretreatment of cisatracurium 0.005 mg/kg.

Group Type: EXPERIMENTAL

Cisatracurium

Intervention Type: DRUG

Different doses of cisatracurium pretreatment

Cisatracurium 0.01 mg/kg

The group received pretreatment of cisatracurium 0.01 mg/kg

Group Type: EXPERIMENTAL

Cisatracurium

Intervention Type: DRUG

Different doses of cisatracurium pretreatment

Cisatracurium 0.02 mg/kg

The group received pretreatment of cisatracurium 0.02 mg/kg

Group Type: EXPERIMENTAL

Cisatracurium

Intervention Type: DRUG

Different doses of cisatracurium pretreatment

Interventions

Cisatracurium

Different doses of cisatracurium pretreatment

Intervention Type: DRUG

Other Intervention Names

Dose

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou No.1 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongsheng Zhang, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

YZYY-610

Identifier Type: -

Identifier Source: org_study_id