Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

Effects of Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 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 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

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 groups received different pretreatments of cisatracurium.; Other Names: Dose
Experimental: Cisatracurium 0.01 mg/kg; The group received pretreatment of cisatracurium 0.01 mg/kg.	Drug: Cisatracurium; Different groups received different pretreatments of cisatracurium.; Other Names: Dose
Experimental: Cisatracurium 0.02 mg/kg; The group received pretreatment of cisatracurium 0.02 mg/kg.	Drug: Cisatracurium; Different groups received different pretreatments of cisatracurium.; Other Names: Dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
Side effects of the pretreatment of cisatracurium	From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes

Collaborators and Investigators

• Sponsor: Zhuan Zhang
• Investigators: Study Director: Xin-nong Liu, Professor, Yangzhou No. 1 Peoples' Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: October 1, 2015

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: ZZ0716