Comparison of the prophylactic effect of intravenous Propofol, Dexamethasone and Ondansetron on post operative nausea and vomiting in elective cesarean section under spinal anesthesia
Determining the prophylactic effect of Propofol, Dexamethasone and Ondansetron on post operative nausea and vomiting in elective cesarean section under spinal anesthesia
Design
In this double-blind clinical trial parallel study (phase 3), 120 pregnant women candidates for cesarean section undergoing spinal anesthesia were included. patients were randomly divided into four groups using generated computer numbers. Patients were injected with 0.05 Mg/kg of Ondansetron in group 1, 0.1 Mg/kg of Dexamethasone in group 2, 0.2 Mg/kg of Propofol in group 3 and normal saline in group 4 (control group).
Settings and conduct
This study was performed on women undergoing elective cesarean section under spinal anesthesia admitted to Urmia Shahid Motahari.
Participants/Inclusion and exclusion criteria
In this double-blind clinical trial study, women in the age range of 15 to 35 years who were candidates for cesarean section were included. Women with gastrointestinal disorders, eclampsia and preeclampsia, a history of taking anti-depression drugs, a history of surgery, motion sickness and weight more than 100 kg were excluded.
Intervention groups
Participants were randomly divided into four groups:
Patients were injected with 0.05 Mg/kg of Ondansetron in group 1, 0.1 Mg/kg of Dexamethasone in group 2, 0.2 Mg/kg of Propofol in group 3 and normal saline in group 4 (control group).
Main outcome variables
Nausea and vomiting after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170408033280N3
Registration date:2020-12-12, 1399/09/22
Registration timing:retrospective
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Ebrahim Hassani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
ehassani@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-01-20, 1398/10/30
Scientific title
Comparison of the prophylactic effect of intravenous Propofol, Dexamethasone and Ondansetron on post operative nausea and vomiting in elective cesarean section under spinal anesthesia
Public title
The effect of intravenous Propofol, Dexamethasone and Ondansetron in preventing nausea and vomiting after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women under cesarean section
Age group 15-35 years old
American Society of Anesthesiologists classification system I and II (ASA II and ASA II)
Exclusion criteria:
Having a history of anti depression drugs consumption
Gastrointestinal disorders
Motion sickness
Weight >100 Kg
Having a history of other surgeries
Patients with preeclampsia and eclampsia during pregnancy
Taking anti-nausea and vomiting medications 24 hours before cesarean section
Age
From 15 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using Random allocation computer software.By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients allocated into four groups according computer generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blind clinical trial. participants and researcher were unaware about the patient belonged to the interventions or a control groups. The drugs were injected by an anesthesiologist (other than the lead researcher) who was unaware of the content of the study.
Placebo
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 Ave, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.UMSU.REC.1398.085
Health conditions studied
1
Description of health condition studied
Nausea and vomiting after cesarean section
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
Recovery and six hours after surgery
Method of measurement
Asking the patient
2
Description
Vomoting
Timepoint
Recovery and six hours after surgery
Method of measurement
Push out stomach contents from the mouth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group 1: Received 0.05 Mg/kg of Ondansetron from Kaspian-Farma company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.
Category
Treatment - Drugs
2
Description
Intervention group: group 2: Received 0.1 Mg/kg of Dexamethasone from Shimi-Daru company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.
Category
Treatment - Drugs
3
Description
Intervention group: group 3: Received 0.2 Mg/kg of Propofol from Tehran-Shimi company (Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.