Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

Fasciculations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502032
• Other study ID #: ZZ0716
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2015
• Last updated: October 8, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• 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 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 Design

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

Related Conditions & MeSH terms

• Fasciculation
• Fasciculations

Intervention

Drug:
• Cisatracurium
Different groups received different pretreatments of cisatracurium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of fasciculations		After the injection of succinylcholine for 1.5 minutes	Yes
Secondary	Side effects of the pretreatment of cisatracurium		From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes	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 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