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Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

Primary Purpose

Fasciculations

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cisatracurium
Sponsored by
Zhuan Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fasciculations

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 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

    First Posted
    July 16, 2015
    Last Updated
    October 8, 2015
    Sponsor
    Zhuan Zhang
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    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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