A comparative study of the effects of Dexamethasone and Ondansetron on nausea and vomiting in cesarean section under spinal anesthesia by Bupivacaine (Marcaine)
Considering the importance of controlling and preventing postoperative nausea and vomiting, and the availability and affordability of Dexamethasone and Endonestrone, we decided to investigate their effects on reducing these complications
Design
A double-blind, randomized clinical trial without control group, With parallel groups
Settings and conduct
The study population include all patients who are referred to the operating room of the Asali charity Hospital for elective cesarean section.
Sampling method: The method of selecting the samples is available and assigning them to the groups under study using stratified random blocks method.
Participants/Inclusion and exclusion criteria
inclusion criteria: Include all patients who have been referred for elective cesarean section; ASA class one and two; In fertility; Patients with normal, mild to moderate stress, anxiety and depression; and patients with bupivacaine 0.5% spinal anesthesia.
exclusion creteria:
Patients with gestational toxicity; History of motion sickness, history of meniere syndrome, migraine; BMI higher than 40; History and practice of post-implementation; Severe or severe stress, anxiety and depression; smoking and the use of opiate drugs; People who are not willing to cooperate; patients who have a 5% lidocaine spinal anesthetic; Patients receiving atropine during surgery.
Intervention groups
Patients will be randomly divided into two equal-sized groups. In one group, Dexamethasone will be prescribed at the dose of 8 mg after the spinal anesthesia, and the second group will receive 4 mg Ondansetron after the spinal anesthesia.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180210038681N1
Registration date:2018-05-01, 1397/02/11
Registration timing:registered_while_recruiting
Last update:2018-05-01, 1397/02/11
Update count:0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Jahanbahsh Rezanejadei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 6226
Email address
rezanezhadi.j@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of Dexamethasone and Ondansetron on nausea and vomiting in cesarean section under spinal anesthesia by Bupivacaine (Marcaine)
Public title
The effect of dexamethasone and endonestrone premedication on the incidence of nausea and vomiting after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have attended for elective cesarean section
In the ASA class one and two
being in fertility age
Patients with normal, mild or moderate stress, anxiety and depression level
Patients who will undergo spinal anesthesia with bupivacaine 0.5%
Exclusion criteria:
Patients suffering from pregnancy toxicity ( eclampsia- preclampsia) or history of motion sickness, history of meniere disease, and migraine
BMI greater than 40
history of PONV( post opreative neusea and vomiting )
severe or very severe level Stress , anxiety and depression
Cigarette smoking and opoid drug consumption
Patients that donot to cooperate
Patients who undergo spinal anesthesia with lidocaine 5%
Patients who receive atropine during opreation
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected purposefully and were assigned to the study groups using the stratified randomized blocks. nullipara/multi para pregnancy is considered as strata in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Anesthesiologist was not aware of the type of drug used to prevent nausea and vomiting. The information was provided as a checklist and given to the inquirer who was not informed about the type of drugs for the patients. The incidence of nausea and vomiting in the patient was recorded 0 , 2 and 6 hours later in the PACU.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Haj Karim Asali charity Hospital, at the begining of Felestin alley, Doctor Shariati Avenue
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.LUMS.REC.1396.290
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea
Timepoint
In PACU (at 0 oclock) and 2 oclock and after 6 oclock, the incidence of nausea and vomiting in the patient
Method of measurement
VAS ( Visual analog scale )
2
Description
Vomiting
Timepoint
At PACU (at the begining) and 2 hours and 6 hours later
Method of measurement
Interview with patient
3
Description
Stress, depression and anxiety
Timepoint
In the recovery before surgery
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (1) used single bolus dose of Dexamethasone (8 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge.
Category
Treatment - Drugs
2
Description
Intervention group (2) used single bolus dose of ondansetrone (4 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj Karim Asali charity Hospital
Full name of responsible person
Jahanbakhsh Razandehadi
Street address
Haj Karim Asali charity Hospital, at the begining of Felestin alley, Doctor Shariati Avenue
City
khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3340 6099
Fax
Email
rezanezhadi.j@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Jahanbashksh Rezanejadei
Street address
Paramedicine and Nutriton Campus , Next to the social security hospital , eastern Goldasht, Khorramabad , Lorestan
City
khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3342 0030
Email
rezanezhadi.j@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Jahanbahsh rezanejadei
Position
eduactor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Paramedicine and Nutriton Campus, Next to the social security hospital, eastern Goldasht
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3342 0030
Email
rezanezhdi.j@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Jahanbakhsh Razanejadi
Position
eductor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Paramedicine and Nutriton Campus, Next to the social security hospital, eastern Goldasht
City
khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3340 6099
Email
rezanezhadi.j@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Jahanbahsh Rezanejadei
Position
Educator
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
No.12 ,Shahid Saberhoshyarei alley, Satarkhan Ave
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3322 6226
Fax
Email
rezanezhadi.j@lums.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
The patients are divided into two groups A and B, and personal information of the patients remains confidential with the researcher.
When the data will become available and for how long
After completing the study, the information is presented in an article and immediately available to the public.
To whom data/document is available
The results are publicly available after printing and publication.
Under which criteria data/document could be used
An analysis of the data delivered is authorized by the written permission of the persons in the article.
From where data/document is obtainable
After publication of the article, people can submit articles by visiting Khorramabad University of Medical Sciences or through their respective websites.
What processes are involved for a request to access data/document
Immediately after referring to the Khorramabad University of Medical Sciences or the relevant websites, the article is available to the referring.