1. Home
  2. Approved trials
  3. » فارسی

Comparison of the Effect of Intravenous Atropine and Hyoscine on the Frequency of Oculocardiac Reflex in Scleral Buckling Surgery: A double-blinded Randomized Controlled Clinical Trial

Protocol summary

Study aim
This clinical study was set out to compare the effects of atropine and hyoscine on the frequency of oculocardiac reflex in patients with scleral buckling surgery.
Design
Three parallel group randomized trial with three blinded participant, investigator and surgeon for preventive effect of anticholinergics on oculocardiac reflex
Settings and conduct
This study is performed in patients with scleral buckling in Khatam Al-Anbia Hospital. After monitoring and intravenous saline injection, induction of anesthesia was performed with 2 mg/kg fentanyl, 0.5 mg/kg atracurium, and 2 mg/kg propofol. After 2 minutes, patients were intubated and after confirmation of the location, the patients were placed under mechanical ventilation with a volume of 8 cc/kg. Respiratory rate was adjusted based on capnography and ETco2 was maintained in the range of 35-45 mmHg. Then, according to the protocol, the injection was performed in the control group (distilled water), the atropine group , and the hyoscine group .The solutions were prepared in two ml volume, the patient and the researcher that evaluating the symptoms did not know the injected drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria were American Society of Anesthesiologists (ASA) class I and II. Exclusion criteria were : ASA > II, uncontrolled hypertension, coronary artery disease, respiratory disease, addiction, preoperative beta-blocker use, and hypersensitivity to hyoscine and atropine.
Intervention groups
After induction, in the control group distilled water, in the atropine group 0.02 mg/kg up to a maximum of 0.5 mg, and in the hyoscine group 0.2 mg/kg was injected
Main outcome variables
Patients' vital signs, blood pressure, heart rate, and capnography were recorded before induction, after induction, and intubation , at the beginning of surgery and every 10 minutes until the end of the operation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120307009229N6
Registration date: 2022-02-14, 1400/11/25
Registration timing: retrospective

Last update: 2022-02-14, 1400/11/25
Update count: 0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Mehryar Taghavi Gilani
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
taghavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2020-03-08, 1398/12/18
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2020-07-10, 1399/04/20
Trial completion date
2020-07-10, 1399/04/20
Scientific title
Comparison of the Effect of Intravenous Atropine and Hyoscine on the Frequency of Oculocardiac Reflex in Scleral Buckling Surgery: A double-blinded Randomized Controlled Clinical Trial
Public title
Frequency of Oculocardiac Reflex in scleral buckling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) class I and II
Exclusion criteria:
ASA > II, uncontrolled hypertension, coronary artery disease, respiratory disease, addiction, preoperative beta-blocker use, hypersensitivity to hyoscine and atropine
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 75
Actual sample size reached: 25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used and each patient randomly removes a sealed envelope and announces the number inside it to the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded clinical study, the drugs are injected by one person and each drug is prepared in a 2 cc syringe (2ml solution), the researcher who recorded the information and the patient did not know the type of drug prescribed
Placebo
Used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Science
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184542322
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.093

Health conditions studied

1

Description of health condition studied
Hypotony of eye and scleral buckling surgery
ICD-10 code
H44.4
ICD-10 code description
Hypotony of eye

Primary outcomes

1

Description
oculocardiac reflex
Timepoint
before induction, after induction, and implantation of the endotracheal tube, at the beginning of surgery and every 10 minutes until the end of the operation
Method of measurement
heart rate changes

Secondary outcomes

1

Description
blood pressure
Timepoint
before induction, after induction, and implantation of the endotracheal tube, at the beginning of surgery and every 10 minutes until the end of the operation
Method of measurement
intraoperative monitoring

Intervention groups

1

Description
first Intervention group- Hyoscine n-butyl bromide is injected in 20 mg and 2 ml of tolidaru before induction of anesthesia.
Category
Prevention

2

Description
second Intervention group: Atropine sulfate is injected 0.02 mg/kg up to 0.5 mg in two ml made by Caspian before induction of anesthesia.
Category
Prevention

3

Description
Control group- Distilled water is injected in two ml before induction of anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
mehryar taghavi gilani
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184542322
Phone
+98 51 3858 3878
Email
taghavim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mehryar taghavi gilani
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184532435
Phone
+98 51 3858 3878
Email
taghavim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mehryar taghavi gilani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184532435
Phone
+98 51 3858 3878
Email
taghavim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mehryar taghavi gilani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184532435
Phone
+98 51 3858 3878
Email
taghavim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mehryar taghavi gilani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
bahar str
City
mashhad
Province
Razavi Khorasan
Postal code
9184532435
Phone
+98 51 3858 3878
Email
taghavim@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic characteristics of patients such as age, sex and weight, as well as changes in heart rate and blood pressure during scleral buckling surgery in patients are evaluated and compared with each other.
When the data will become available and for how long
After 2022 and the publication of articles in scientific journals
To whom data/document is available
medical students and professors and journal editors
Under which criteria data/document could be used
except of patient nominal information, patient profiles such as age, sex, weight, and intraoperative hemodynamic changes such as heart rate and blood pressure are available, and individuals are allowed to perform any evaluation and analysis.
From where data/document is obtainable
To access the study information in the following ways, people can apply and contact to Mehryar Taghavi Gilani tel: 0513858878 taghavim@mums.ac.ir Address: Mashhad Imam Reza Hospital - Anesthesia Ward
What processes are involved for a request to access data/document
Contact Mehryar Taghavi Gilani for any information about the type and method of study and statistical results, as well as the Data obtained. Phone 0513858878
Comments
Loading...