Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

Fasciculation Clinical Trial

Official title:

Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481193
• Other study ID #: YZYY-610
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2015
• Last updated: June 22, 2015
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: Yangzhou No.1 People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fasciculation
• Myalgia

Intervention

Drug:
• Cisatracurium
Different doses of cisatracurium pretreatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou No.1 People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of fasciculations		After the injection of succinylcholine for 1.5 minutes	Yes
Secondary	Side effects of the pretreatment of cisatracurium		At the time of three minutes after the pretreatment of cisatracurium	Yes
Secondary	The time to maximal depression of twitch		From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes	Yes
Secondary	The extent to maximal depression of twitch		From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes	Yes
Secondary	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	Yes
Secondary	The grades of endotracheal intubation		At intubating time	Yes
Secondary	The changes of serum potassium		After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation	Yes
Secondary	Myalgia at 24 hours postoperatively		At 24 hours postoperatively	Yes