Comparison of Changes in Heart Rate and Development Cardiac Arrhythmia following Reversal of Muscle Relaxation by Two Combination :Atropine Plus Neosigmine or Glycopyrrolate Plus Neostigmin
Objective: In this study two drug combinations; atropine-neostigmine and glycopyrrolate-neostigmine were compared according to their effects on heart rate, blood pressure and arrythmogenicity.
Research Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple.
Inclusion criteria: patient between 50-70 year old, ASA physical status I, undergoing cataract surgery under general anesthesia with endotracheal tube or laryngeal mask.
Exclusion criteria: Patients with electrolyte abnormalities, cardiovascular problems and using the drugs that affect heart rate and also patients with difficult intubation were excluded from the study.
Intervention: One hundred elderly patient between 50-70 year old with ASA physical status I, undergoing cataract surgery were randomly allocated in two groups : I) glycopyrrolate-neostigmine (G) and II) Atropine- neostigmine (A)At the end of the operation reversal of the muscle relaxant effects in group I was conducted with combination of atropine-neostigmine and glycopyrrolate-neostigmine in group ІІ.
Heart rate, arrhythmia and blood pressure were recorded at 4 time points: 1) before induction of anesthesia .2) after administration of anesthetic drugs and before drug reversal of muscle relaxation 3) Three minutes after reversal of neuromuscular blockade. 4) ten minutes after reversal of neuromuscular blockade.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021019470N16
Registration date:2015-04-21, 1394/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-21, 1394/02/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Changes in Heart Rate and Development Cardiac Arrhythmia following Reversal of Muscle Relaxation by Two Combination :Atropine Plus Neosigmine or Glycopyrrolate Plus Neostigmin
Public title
Comparison of Changes in Heart Rate following Reversal of Muscle Relaxation by Two Combination :Atropine Plus Neosigmine or Glycopyrrolate Plus Neostigmin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient between 50-70 year old, ASA physical status I, undergoing cataract surgery under general anesthesia with endotracheal tube or laryngeal mask.
Exclusion criteria: Patients with electrolyte abnormalities, cardiovascular problems and using the drugs that affect heart rate and also patients with difficult intubation were excluded from the study.
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ct-88-4553
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Senile Cataract
Primary outcomes
1
Description
Heart Rate
Timepoint
1) before induction of anesthesia .2) after administration of anesthetic drugs and before drug reversal of muscle relaxation 3) Three minutes after reversal of neuromuscular blockade. 4) ten minutes after reversal of neuromuscular blockade.
Method of measurement
EKG
2
Description
Arrhythmia
Timepoint
1) before induction of anesthesia .2) after administration of anesthetic drugs and before drug reversal of muscle relaxation 3) Three minutes after reversal of neuromuscular blockade. 4) ten minutes after reversal of neuromuscular blockade.
Method of measurement
EKG
3
Description
Blood Pressure
Timepoint
1) before induction of anesthesia .2) after administration of anesthetic drugs and before drug reversal of muscle relaxation 3) Three minutes after reversal of neuromuscular blockade. 4) ten minutes after reversal of neuromuscular blockade.
Method of measurement
Measuring the blood pressure
Secondary outcomes
empty
Intervention groups
1
Description
at the end of the operation reversal of the muscle relaxant effects in group I was conducted with combination of atropine-neostigmine
Category
Treatment - Drugs
2
Description
at the end of the operation reversal of the muscle relaxant effects in group ІІ was conducted with combination of glycopyrrolate-neostigmine .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Mehdi Zadmehr
Street address
Namazee Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mehdi Zadmehr
Position
Physician
Other areas of specialty/work
Street address
Department of anesthesia, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mansoor Masjedi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
mansoormasjedi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)