The adjuvant effect of dexamethasone to ondansetron or metoclopramide in prevention of nausea and vomiting after spinal anesthesia for elective caesarian section
The adjuvant effect of dexamethasone to ondansetron or metoclopramide in the prevention of nausea and vomiting after spinal anesthesia for elective cesarean section.
Design
This study will be done in the operating room. All of the drugs solution of this study will be prepared by only one person who is aware of the study's grouping, in 5 ml syringes in the same shape. Anesthesiologist, patients, and all medical staff that will collaborate in the study will not aware of the drug allocated to each patient.
Settings and conduct
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 150 patients who will be undergoing elective cesarean section under spinal anesthesia will be enrolled. Eligible patients will be randomly allocated into two equal A and B groups by block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
adult female with ASA class I or II, age between the 18 and 35, who are planned to undergo elective cesarean section under spinal anesthesia.
Exclusion criteria: ASA class of III or IV, Allergies to local anesthetics and study medication, Hypertension caused by pregnancy, Patients whom emergency cesarean section is required.
Intervention groups
Intervention group 1 or DO group: dexamethasone 8 mg (manufactured by Tehran-Shimi Company) IV plus ondansetron 4 mg (manufactured by Caspin Company) is administered intravenously 10 minutes before anesthesia; Intervention group 2 or group DM: dexamethasone (manufactured by Tehran-Shimi Company) 8 mg IV, metoclopramide (manufactured by Caspin Company ) 10 mg IV administered intravenously 10 minutes before anesthesia.
Main outcome variables
Nausea and Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221127056627N1
Registration date:2022-12-04, 1401/09/13
Registration timing:registered_while_recruiting
Last update:2022-12-04, 1401/09/13
Update count:0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Zeinabsadat Fattahi Saravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
zefattahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The adjuvant effect of dexamethasone to ondansetron or metoclopramide in prevention of nausea and vomiting after spinal anesthesia for elective caesarian section
Public title
Survey the effect of adding dexamethasone to ondansetrone or metoclopramide to increase the effect of these drugs in prevention of nausea and vomiting after caesarian section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult women with ASA grade I or II (American Society of Anesthesiology classification)
Women between 18 and 35 years old
Women having elective caesarean section under spinal anesthesia
Exclusion criteria:
ASA class of III or IV
pregnancy induced Hypertension
Patients who have received steroid medication
positive history of prolonged QT interval
patients who refuced to do spinal anesthesia for her
Age
From 18 years old to 35 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 25 blocks of size 6 will be selected randomly and
patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Antiemetic drugs are provided in the form of syringes containing 5 ml of normal saline solution by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.SUMS.MED.REC.1401.216
Health conditions studied
1
Description of health condition studied
esarean section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
Nausea
Timepoint
3 minutes and 15 minutes before the operation and 4 hours after the operation
Method of measurement
Score points based on Bellavia criteria
2
Description
Vomiting
Timepoint
3 minutes and 15 minutes before the operation and 4 hours after the operation.
Method of measurement
Score points based on Bellavia criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 or DO group: dexamethasone 8 mg (manufactured by Tehran-Shimi Company) IV plus ondansetron 4 mg (manufactured by Caspin Company ) is administered intravenously ten minutes before anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2 or group DM: dexamethasone 8 mg((Manufactured by Tehran-Shimi Company) intravenously., and metoclopramide 10 mg (Made by Caspian Company) administered intravenously 10 minutes before anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Mojtaba Soukhakian
Street address
Ghadir Mother and Child Hospital-the beginning of Golshan town -above the Quran gate -Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۴۴۹۹۵۳۷۷
Phone
+98 71 3227 9701
Email
Motherhosp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpoor
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Sookhakian
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
0987136474270
Email
dr.sookhian.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinabsadat Fattahi
Position
Pediatric Anesthesiology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
parniafattahi@rocketmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Saeedizade
Position
Research Assisstant
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
009836281460
Email
saeedi.hamide@gmail.com
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