Comparative Study of the Effect of Ondansetron and Ginger on Nausea/ Vomiting, Shivering and Headache after Spinal Anesthesia during and after Cesarean Section
Comparison of the Effects of Ondansetron and Ginger on Nausea/Vomiting, Shivering and Headache after Spinal Anesthesia during and after Cesarean Section
Design
Clinical trial with control group, with parallel, blinded, randomized phase 3 groups on 150 patients. Six random block method will be used for randomization.
Settings and conduct
The research community will be all pregnant mothers who visit the Fatemieh Hospital in Hamadan for cesarean section under spinal anesthesia.The participant, clinical caregiver and statistical analyzer will not be aware of the groups and the type of intervention.After coordination with the anesthesia team and the gynecological surgery team, the intervention will be performed.The condition of all participants will be the same including anesthesia, operating room temperature, coverage and type of serum received.If the desired consequences worsen, the medication will be prescribed according to the anesthesiologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age range of 20 to 40 years; 2. Physical status 1 or 2 in terms of ASA criteria; 3. Complete gestational age and singleton; 4.Cesarean candidate under spinal anesthesia.
Exclusion criteria: 1. Unwilling to participate in the study; 2. History of mental disorders; 3. Body mass index greater than 35; 4. Meniere's disease; 5. Digestive Disease; 6. Frequent Dora holes and failed spinal anesthesia; 7. Allergy to ondansetron or ginger
Intervention groups
A) Ginger group: Taking one oral ginger capsule (1000 mg) with 30 ml of water one hour before receiving spinal anesthesia. B) Ondansetron group: Taking one ondansetron capsule (16 mg) with 30 ml of water one hour before receiving spinal anesthesia. C) Control group: Taking a placebo capsule (containing rice flour) with 30 ml of water one hour before receiving spinal anesthesia.
Main outcome variables
Nausea/ Vomiting; Shivering; Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220614055172N1
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Sahar Alizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5612 8866
Email address
s.alizadeh@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Effect of Ondansetron and Ginger on Nausea/ Vomiting, Shivering and Headache after Spinal Anesthesia during and after Cesarean Section
Public title
The Effect of Ondansetron and Ginger on Nausea/ Vomiting, Shivering and Headache in Cesarean Section Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 20 to 40 years
Physical status 1 or 2 in terms of ASA criteria
Complete gestational age and singleton
Cesarean candidate under spinal anesthesia
Exclusion criteria:
Unwilling to participate in the study
History of mental disorders
Body mass index greater than 35
Meniere's disease
Digestive Disease
Frequent Dora holes and failed spinal anesthesia
Allergy to Ondansetron or Ginger
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In the random block sampling method, different modes of three groups are written on six cards and each in an envelope is placed in the package. These envelopes are placed in a box, and the researcher does not know which research units will be placed in before selecting the card. Before exposure to the research units, the midwife picking up one of the envelopes from the box without awareness of the study and groups determines which group that will be included in the study, respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participants and clinical caregivers and data analyzer will be informed of the generality and method of implementation of the study, but will not be aware of the groups and the type of intervention received That is, the participant, clinical caregiver and data analyzer will be unaware of where each participant is and what intervention has received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.UMSHA.REC.1401.316
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
Z38.01
ICD-10 code description
Single liveborn infant, delivered by cesarean
Primary outcomes
1
Description
Nausea based on visual analog scale score
Timepoint
During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed
Method of measurement
Visual analog scale
2
Description
Vomiting based on the vomiting frequency checklist
Timepoint
During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed
Method of measurement
Vomiting frequency checklist
3
Description
Shivering based on the standard shivering scale score
Timepoint
During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed
Method of measurement
Standard Shivering scale based on Crossley and Mahajan criteria
4
Description
Headache based on visual analog scale score
Timepoint
During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: This group is the ginger group, which will first be prepared as Zintoma oral capsules (250 mg) produced by Gol Daroo Pharmaceutical Company. Then, 1000 mg ginger capsule will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given a ginger capsule (1000 mg) with 30 ml of water one hour before receiving spinal anesthesia.
Category
Prevention
2
Description
Second Intervention group: This group is ondansetron group, which will first be prepared as ondansetron tablets (16 mg) produced by Exir Pharmaceutical Company. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given an ondansetron capsule (16 mg) with 30 ml of water one hour before receiving spinal anesthesia.
Category
Prevention
3
Description
Control group: Placebo capsule (containing rice flour) will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and gynecological surgery team, a placebo capsule (containing rice flour) with 30 ml of water one hour before The patient will be given spinal anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital
Full name of responsible person
Sahar Alizade
Street address
Fatemieh Hospital, Pasdaran St.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3825 5890
Fax
+98 81 3825 1288
Email
h-fatemiyeh@umsha.ac.ir
Web page address
https://fth.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
Info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Alizade
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square,
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
arielalizade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square,
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
Behzadiman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Alizade
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square,
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
arielalizade@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
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
All personal data is shared after unidentified individuals. Includes demographic data and data on the severity of Nausea/Vomiting, Shivering, and Headache.
When the data will become available and for how long
The data is shared three months after the publication of the results.
To whom data/document is available
All researchers can apply for the data.
Under which criteria data/document could be used
The data is provided provided that they first have a clear purpose for using the data. Secondly, wherever this data is to be used, the primary data source should be mentioned.
From where data/document is obtainable
Can use the the following e-mail address to receive the data.
Behzadiman@yahoo.com
What processes are involved for a request to access data/document
After sending the request to the e-mail address, the data will be sent as soon as possible.