Comparison of the effects of ondansetron and metoclopramide on blood pressure of patients after spinal anesthesia during cesarean section
Design
Clinical trial without control group, with parallel, double-blind, randomized groups in which 48 patients with a size of 4 blocks will be randomly assigned to two groups.
Settings and conduct
Pregnant women 20-40 years old who are candidates for elective cesarean section referred to the Babol Clerical Training Center are randomly divided into two groups. Intravenous face
Intervention group 2: 30 minutes before the start of spinal anesthesia 4 mg of ondansetron (elixir pharmacy) once intravenously
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnant women with a pregnancy over 34 weeks are candidates for elective cesarean section, ASA (American Society Anesthesiology) Class I,II
Exclusion criteria: Allergy to ondansetron or metoclopramide, Use of antiemetic in the last 24 hours, Gastrointestinal diseases, Preeclampsia
Intervention groups
Intervention group 1: 30 minutes before the start of spinal anesthesia 10 mg of metoclopramide (Amin Pharmacy) once intravenously
Intervention group 2: 30 minutes before the start of spinal anesthesia 4 mg of ondansetron (Exir pharmacy) once intravenously
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044907N3
Registration date:2021-08-08, 1400/05/17
Registration timing:registered_while_recruiting
Last update:2021-08-08, 1400/05/17
Update count:0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
seyed hossein hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 3301
Email address
a.hamidi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-07, 1400/05/16
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ondansetron and metoclopramide on blood pressure of patients after spinal anesthesia during cesarean section
Public title
Comparison of the effect of ondansetron with metoclopramide on blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with a pregnancy over 34 weeks are candidates for elective cesarean section
ASA (American Society Anesthesiology) Class I,II
Exclusion criteria:
Allergy to ondansetron or metoclopramide
Use of antiemetic in the last 24 hours
Gastrointestinal diseases
Preeclampsia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using permutation blocks with instrument 4. Thus, 4 blocks consist of random combinations of compounds 2 to A (metoclopramide) and 2 to B (ondansetron). Random sequencing of blocks will be done by a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study, the drugs are diluted with 10 cc of normal saline before injection by a colleague and prepared in coded syringes. As a result, neither patients nor the anesthesiologist will know the type of drug prescribed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.MUBABOL.REC.1400.148
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
074.6
ICD-10 code description
other cpmplications of spinal and epidural anesthesia during labour and delivery
Primary outcomes
1
Description
Blood Pressure
Timepoint
Basic before spinal anesthesia every two minutes to a quarter, then every five minutes until the end of surgery
Method of measurement
In a non-invasive way with the monitoring device of Saadat Company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 minutes before the start of spinal anesthesia 10 mg of metoclopramide (Amin Pharmacy) once intravenously
Category
Treatment - Drugs
2
Description
Intervention group: 30 minutes before the start of spinal anesthesia 4 mg of ondansetron (Exir pharmacy) once intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Seyed Hossein Hamidi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
s.hosseinhamidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?