Protocol summary

Study aim
A lot of surgeries are performed in the world every year, so it is necessary to take the necessary precautions to ensure the safety of the patient as much as possible. A combination of atropine and neostigmine drugs under the name of reverse, which is injected at the end of surgery to neutralize muscle relaxant drugs, can affect cardiovascular stability. The purpose of this study is to find a solution to minimize this effect.
Design
This study is a double-blind clinical trial on 69 hospitalized patients who are candidates for various surgeries, who were randomly divided into three groups based on the speed of reverse injection by giving sheets A, B, and C.
Settings and conduct
A double-blind study involving the researcher and the patient was conducted on inpatients who were candidates for various surgeries in 1400 at Shahid Rahmon Hospital, Yazd, and the information was recorded using a checklist, and the samples were randomly divided into three groups in terms of injection time. They were divided in reverse.
Participants/Inclusion and exclusion criteria
The criteria for inclusion in the study were patients aged 16-50 years, hemoglobin levels higher than 14 g/dL with ASA.PS class one anesthesia. The exclusion criteria were patients with bleeding more than 10% of the blood volume, having cardiac, vascular and respiratory disorders, receiving drugs affecting the heart rate or central nervous system, and patients with a history of substance abuse, drug sensitivity, and egg yolk sensitivity.
Intervention groups
A combination of atropine and neostigmine drugs under the name of reverse, which is equal in each group in terms of dosage (1.5 mg of atropine and 3 mg of neostigmine) and differs only in terms of injection speed (10 seconds, 1 minute, 3 minutes).
Main outcome variables
pulse rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230405057822N1
Registration date: 2024-01-26, 1402/11/06
Registration timing: retrospective

Last update: 2024-01-26, 1402/11/06
Update count: 0
Registration date
2024-01-26, 1402/11/06
Registrant information
Name
Hamid Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 8626
Email address
mirhosseini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
2021-10-23, 1400/08/01
Actual recruitment end date
2023-04-21, 1402/02/01
Trial completion date
2023-04-21, 1402/02/01
Scientific title
Investigating the effect of the injection speed of the combination of neostigmine and atropine on the heart rate of patients under general anesthesia
Public title
Investigating the effect of the injection speed of the combination of neostigmine and atropine on the heart rate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin level above 14 g/dL Anesthesia class one ASA.PS
Exclusion criteria:
Patients with bleeding more than 10% blood volume Patients with a history of substance abuse and drug allergy and egg yolk allergy Having cardiac, vascular and respiratory disorders Receiving drugs that affect heart rate or central nervous system
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 69
Actual sample size reached: 69
Randomization (investigator's opinion)
Randomized
Randomization description
The studied samples were randomly divided into three groups based on the speed of reverse injection by giving sheets A, B, and C. The injection speed of the first group was 10 seconds, the second group was 1 minute, and the third group was 3 minutes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher was not aware of the speed of the injection of neostigmine and atropine, which was done by the research colleague. Since the patient was not conscious at the time of the injection, he did not know the type of intervention.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Imam Hossein square, at the beginning of the student boulevard, Imam Reza,research educational complex
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Approval date
2021-10-12, 1400/07/20
Ethics committee reference number
IR.SSU.REC.1400.210

Health conditions studied

1

Description of health condition studied
the patients under going general anesthesia
ICD-10 code
Z41.2
ICD-10 code description
Encounter for routine and ritual male circumcision

Primary outcomes

1

Description
pulse rate
Timepoint
10 seconds , 1minute , 3minutes
Method of measurement
monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: reverse injection with a speed of 10 seconds including 3 mg of neostigmine and 1.5 mg of atropine to the first 23 patients.
Category
Treatment - Drugs

2

Description
The second intervention group: reverse injection with a speed of 1 minute including 3 mg of neostigmine and 1.5 mg of atropine to 23 second patients.
Category
Treatment - Drugs

3

Description
The third intervention group: reverse injection with a speed of 3 minutes including 3 mg of neostigmine and 1.5 mg of atropine to 23 third patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Shahid Rahnamoun Hospital
Full name of responsible person
Mohammad Hossein Dehghani
Street address
Farokhi Ave , YAZD
City
Yazd
Province
Yazd
Postal code
8916188135
Phone
+98 35 3626 0001
Email
Paramed@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.seyed Mahdi Hashemi
Street address
Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916188135
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hamid Mirhosseini
Position
Assiciate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Daneshjoo
City
Yazd
Province
Yazd
Postal code
8916188135
Phone
+98 35 3623 8626
Fax
Email
mirhosseini@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hamid Mirhosseini
Position
Assiciate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Daneshjoo
City
Yazd
Province
Yazd
Postal code
8916188135
Phone
+98 35 3623 8626
Fax
Email
mirhosseini@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Saleh Forghani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
41 Alley, Shahid Rajaee St.
City
Yazd
Province
Yazd
Postal code
8918983387
Phone
+98 35 3622 0326
Email
msaleh.forghani@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Total data
When the data will become available and for how long
3 months after printing the data
To whom data/document is available
Anesthesiologists and experts
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
To receive, contact msaleh.forghani@gmail.com
What processes are involved for a request to access data/document
It will be sent after the applicant's identity and documents are authenticated
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