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
About this trial
This is an interventional treatment trial for Bradycardia focused on measuring heart rate, neostigmine, atropine, dosage
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.
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
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
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0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant
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