- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02502032
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
October 8, 2015 updated by: Zhuan Zhang
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
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisatracurium 0.005 mg/kg
The group received pretreatment of cisatracurium 0.005 mg/kg.
|
Different groups received different pretreatments of cisatracurium.
Other Names:
|
Experimental: Cisatracurium 0.01 mg/kg
The group received pretreatment of cisatracurium 0.01 mg/kg.
|
Different groups received different pretreatments of cisatracurium.
Other Names:
|
Experimental: Cisatracurium 0.02 mg/kg
The group received pretreatment of cisatracurium 0.02 mg/kg.
|
Different groups received different pretreatments of cisatracurium.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of fasciculations
Time Frame: After the injection of succinylcholine for 1.5 minutes
|
After the injection of succinylcholine for 1.5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time to maximal depression of twitch
Time Frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
|
From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
|
The extent to maximal depression of twitch
Time Frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
|
From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
|
The grades of endotracheal intubation
Time Frame: At intubating time
|
At intubating time
|
The changes of serum potassium
Time Frame: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
|
After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
|
Myalgia at 24 hours postoperatively
Time Frame: At 24 hours postoperatively
|
At 24 hours postoperatively
|
Side effects of the pretreatment of cisatracurium
Time Frame: From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes
|
From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Xin-nong Liu, Professor, Yangzhou No. 1 Peoples' Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- ZZ0716
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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