Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02186132
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2014-07-07
Brief Title:
06 vs 12 mg Atropine Together With Neostigmine 25 mg on Heart Rate in Patient Receiving Muscle Relaxant
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
The Effect of 06 vs 12 Milligram Atropine Together With Neostigmine 25 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 mg of neostigmine and 12 mg of atropine
Tribuddharat S ey al 1 has demonstrated that after giving 09 mg atropine together with 25 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beatsmin bpm At 9 and 10 minutes after administration of the drugs the mean heart rate were decrease 09 and 16 bpm In the control group which receiving 12 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 7443 1182 bpm1
Salem MG et al 2 has demonstrated that after receiving 12 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 0015 mgkg of atropine 3 minutes before 003 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 06 mg atropine and 25 mg neostigmine for the reversal of muscle relaxant compare to 12 mg atropine
Tribuddharat S ey al 1 has demonstrated that after giving 09 mg atropine together with 25 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beatsmin bpm At 9 and 10 minutes after administration of the drugs the mean heart rate were decrease 09 and 16 bpm In the control group which receiving 12 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 7443 1182 bpm1
Salem MG et al 2 has demonstrated that after receiving 12 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 0015 mgkg of atropine 3 minutes before 003 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 06 mg atropine and 25 mg neostigmine for the reversal of muscle relaxant compare to 12 mg atropine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None