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Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

Primary Purpose

Fasciculation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cisatracurium
Sponsored by
Yangzhou No.1 People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fasciculation focused on measuring Cisatracurium, Myalgia, Fasciculation, Succinylcholine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    The 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 time for twitch recovery to 20% of its control value
    The grades of endotracheal intubation
    The changes of serum potassium
    Myalgia at 24 hours postoperatively

    Full Information

    First Posted
    June 10, 2015
    Last Updated
    June 22, 2015
    Sponsor
    Yangzhou No.1 People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02481193
    Brief Title
    Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
    Official Title
    Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yangzhou No.1 People's Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fasciculation
    Keywords
    Cisatracurium, Myalgia, Fasciculation, Succinylcholine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (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 doses of cisatracurium pretreatment
    Primary Outcome Measure Information:
    Title
    The 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
    At the time of three minutes after the pretreatment of cisatracurium
    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 time for twitch recovery to 20% of its control value
    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 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

    12. IPD Sharing Statement

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    Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

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