search
Back to results

0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant

Primary Purpose

Bradycardia, Neostigmine Adverse Reaction, Adverse Reaction to Belladonna or Atropine

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atropine 0.6 mg
Atropine 1.2 mg
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring heart rate, neostigmine, atropine, dosage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status 1-3
  • age = or > 18 years
  • patient receiving neuromuscular blocking agent

Exclusion Criteria:

  • baseline heart rate before administration of the study drugs < 65 bpm
  • history of allergy to the study drugs
  • patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
  • history of complete heart block or second degree AV block.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Atropine 0.6 mg

    Atropine 1.2 mg intravenous

    Arm Description

    Atropine 0.6 mg intravenous

    Atropine 1.2 mg intravenous

    Outcomes

    Primary Outcome Measures

    heart rate

    Secondary Outcome Measures

    bradycardia
    heart rate < 60 beats/min

    Full Information

    First Posted
    July 7, 2014
    Last Updated
    July 7, 2014
    Sponsor
    Mahidol University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02186132
    Brief Title
    0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant
    Official Title
    The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine. Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1) Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure. The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group. Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy. The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bradycardia, Neostigmine Adverse Reaction, Adverse Reaction to Belladonna or Atropine
    Keywords
    heart rate, neostigmine, atropine, dosage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atropine 0.6 mg
    Arm Type
    Experimental
    Arm Description
    Atropine 0.6 mg intravenous
    Arm Title
    Atropine 1.2 mg intravenous
    Arm Type
    Active Comparator
    Arm Description
    Atropine 1.2 mg intravenous
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine 0.6 mg
    Intervention Description
    Atropine 0.6 mg intravenous
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine 1.2 mg
    Intervention Description
    Atropine 1.2 mg intravenous
    Primary Outcome Measure Information:
    Title
    heart rate
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    bradycardia
    Description
    heart rate < 60 beats/min
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status 1-3 age = or > 18 years patient receiving neuromuscular blocking agent Exclusion Criteria: baseline heart rate before administration of the study drugs < 65 bpm history of allergy to the study drugs patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin history of complete heart block or second degree AV block.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sirilak Suksompong, MD
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant

    We'll reach out to this number within 24 hrs