A Comparison of the prophylactic effect of granisetron and meperidine on reducing shivering after elective cesarean under spinal anesthesia
Design
A double-blind, randomized clinical trial study with parallel groups and phases 3 on 100 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on elective cesarean patients under spinal anesthesia in Urmia Mahzad Hospital. This study will be a double-blind study and the patient and the researcher who will evaluate the outcomes will be blinded to the allocation of patients into groups.
Participants/Inclusion and exclusion criteria
In this study, 100 patients of 20 to 40 years under elective cesarean section with spinal anesthesia will be enrolled. Women with chronic diseases, hypertension, diabetes, psychological disorders, and surgeries longer than an hour will be excluded.
Intervention groups
In all patients, the spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg granisetron (group A) or 0.4 mg/kg meperidine (group B).
Main outcome variables
shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N10
Registration date:2022-04-12, 1401/01/23
Registration timing:prospective
Last update:2022-04-12, 1401/01/23
Update count:0
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the prophylactic effect of granisetron and meperidine on reducing shivering after elective cesarean under spinal anesthesia
Public title
The effect of granisetron and meperidine on shivering after elective cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective cesarean section with spinal anesthesia
Age between 20 to 40 years
Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)
Women with full-term pregnancy (more than 37 weeks)
Exclusion criteria:
Chronic diseases
Hypertension
Diabetes
Psychological disorders
Drug allergy
Cesarean section more than an hour
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated to groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into granisetron or meperidine groups. Group names will be encoded with the letters A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.UMSU.REC.1401.002
Health conditions studied
1
Description of health condition studied
Shivering after elective cesarean section with spinal anesthesia
ICD-10 code
JB22.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
shivering
Timepoint
Every 5 minutes after surgery
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Mean arterial pressure (MAP)
Timepoint
Before, during and every 5 minutes after surgery
Method of measurement
Monitoring
2
Description
Heart rate
Timepoint
Before, during and every 5 minutes after surgery
Method of measurement
Monitoring
3
Description
Percentage of arterial blood oxygen saturation
Timepoint
Before, during and every 5 minutes after surgery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg granisetron (group A).
Category
Treatment - Other
2
Description
Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg meperidine (group B).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Mahzad hospital
Full name of responsible person
Dr. Tohid Karami
Street address
Hassani Ave, Mahzad hospital, Urmia,Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
karami.t@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
4
Phone
+98 44 3223 4897
Email
gholizadeh.s@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital, Hassani Ave, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
karami.t@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital, Hassani Ave, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57159859497
Phone
+98 44 3346 5079
Email
karami.t@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital, Hassani Ave, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
karami.t@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patient information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
The data will not be published individually and the results will be available as the published articles.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Email address of the corresponding author
What processes are involved for a request to access data/document