Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
Primary Purpose
Fasciculations
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cisatracurium
Sponsored by
About this trial
This is an interventional prevention trial for Fasciculations
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cisatracurium 0.005 mg/kg
Cisatracurium 0.01 mg/kg
Cisatracurium 0.02 mg/kg
Arm Description
The group received pretreatment of cisatracurium 0.005 mg/kg.
The group received pretreatment of cisatracurium 0.01 mg/kg.
The group received pretreatment of cisatracurium 0.02 mg/kg.
Outcomes
Primary Outcome Measures
Presence of fasciculations
Secondary Outcome Measures
Side effects of the pretreatment of cisatracurium
The time to maximal depression of twitch
The extent to maximal depression of twitch
The grades of endotracheal intubation
The changes of serum potassium
Myalgia at 24 hours postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02502032
Brief Title
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
Official Title
Effects of Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuan Zhang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciculations
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cisatracurium 0.005 mg/kg
Arm Type
Experimental
Arm Description
The group received pretreatment of cisatracurium 0.005 mg/kg.
Arm Title
Cisatracurium 0.01 mg/kg
Arm Type
Experimental
Arm Description
The group received pretreatment of cisatracurium 0.01 mg/kg.
Arm Title
Cisatracurium 0.02 mg/kg
Arm Type
Experimental
Arm Description
The group received pretreatment of cisatracurium 0.02 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium
Other Intervention Name(s)
Dose
Intervention Description
Different groups received different pretreatments of cisatracurium.
Primary Outcome Measure Information:
Title
Presence of fasciculations
Time Frame
After the injection of succinylcholine for 1.5 minutes
Secondary Outcome Measure Information:
Title
Side effects of the pretreatment of cisatracurium
Time Frame
From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes
Title
The time to maximal depression of twitch
Time Frame
From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
Title
The extent to maximal depression of twitch
Time Frame
From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
Title
The grades of endotracheal intubation
Time Frame
At intubating time
Title
The changes of serum potassium
Time Frame
After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
Title
Myalgia at 24 hours postoperatively
Time Frame
At 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin-nong Liu, Professor
Organizational Affiliation
Yangzhou No. 1 Peoples' Hospital
Official's Role
Study Director
12. IPD Sharing Statement
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Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
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