Clinical trial NCT02481193: Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
Official title: Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fasciculation
Keywords: Cisatracurium
Myalgia
Fasciculation
Succinylcholine
Lead sponsor: Yangzhou No.1 People's Hospital
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The presence of fasciculations
timeFrame: After the injection of succinylcholine for 1.5 minutes
Secondary outcomes:
measure: Side effects of the pretreatment of cisatracurium
timeFrame: At the time of three minutes after the pretreatment of cisatracurium
measure: The time to maximal depression of twitch
timeFrame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
measure: The extent to maximal depression of twitch
timeFrame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
measure: The time for twitch recovery to 20% of its control value
timeFrame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
measure: The grades of endotracheal intubation
timeFrame: At intubating time
measure: The changes of serum potassium
timeFrame: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
measure: Myalgia at 24 hours postoperatively
timeFrame: At 24 hours postoperatively
Other outcomes:
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