Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

NCT ID: NCT02502032

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-10-31

Brief Summary

To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.

Detailed Description

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 cisatracurium pretreatments, at intubating time, and 5 min after intubation were recorded.

Conditions

Fasciculations

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 groups received different pretreatments of cisatracurium.

Cisatracurium 0.01 mg/kg

The group received pretreatment of cisatracurium 0.01 mg/kg.

Group Type: EXPERIMENTAL

Cisatracurium

Intervention Type: DRUG

Different groups received different pretreatments of cisatracurium.

Cisatracurium 0.02 mg/kg

The group received pretreatment of cisatracurium 0.02 mg/kg.

Group Type: EXPERIMENTAL

Cisatracurium

Intervention Type: DRUG

Different groups received different pretreatments of cisatracurium.

Interventions

Cisatracurium

Different groups received different pretreatments of cisatracurium.

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 the contraindications associated with succinylcholine or cisatracurium;
• Patients taking drugs known to alter the action of neuromuscular blockers;
• Patients 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

Zhuan Zhang

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin-nong Liu, Professor

Role: STUDY_DIRECTOR

Yangzhou No. 1 Peoples' Hospital

Other Identifiers

ZZ0716

Identifier Type: -

Identifier Source: org_study_id