Comparison of the Effect of Ephedrine and Ondansetron on Prevention of Hypotension after Spinal Anesthesia in Cesarean Section
Design
A randomized, Double-blind, Placebo-controlled Clinical trial of Ephedrine and Ondansetron
Settings and conduct
The study will be conducted in the operating room of Mousavi Hospital in Zanjan.
The patient and the clinical evaluator are unaware of the syringe content and patient grouping.
And the type of medication prescribed and the patient group selected by the sealed envelope
Participants/Inclusion and exclusion criteria
Age 18-45 years
Absence of cardiovascular and renal and hepatic disease
No spinal anesthesia contraindications
ASA Class I, II
Intervention groups
Group A is a control group that receives 2 ml of distilled water.
Group B is the ephedrine group, which receives 2 ml of solution containing 10 mg of the drug.
Group C is the ondansetron group that receives 2 ml of solution containing 4 mg of the drug.
Main outcome variables
Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160818029414N5
Registration date:2019-10-12, 1398/07/20
Registration timing:prospective
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
Vahideh Rashtchi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 341 1683
Email address
rashtchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Ephedrine and Ondansetron on Spinal induced Hypotension Cesarean Section
Public title
Effect of Ephedrine and Ondansetron on Hypotension after Spinal Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 year
ASA I,II
Elective Cesarean section under Spinal Anesthesia
Exclusion criteria:
Patient dissatisfaction
Infection at the spinal needle insertion site
High intracranial pressure
Coagulation Disorders
A history of allergy to local anesthetics
Heart, kidney, liver disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned to One of three Study groups using the Sealed Envelope Method
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical evaluator, who is an Anesthetist present in the Operating Room, selects one of the three envelopes in which the letters A, B, C are written and represents the control group, Ephedrine and Ondansetron, and then the syringe containing 2 ml Injections of colorless solution into the control group: Distilled water in the Ephedrine group: 10 mg Ephedrine and in the Ondansetron group: 4 mg of the drug. Assessor and patient from syringe content and classification Groups do not know.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4515613113
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.ZUMS.REC.1398.179
Health conditions studied
1
Description of health condition studied
Hypotension after Spinal Anesthesia
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
Hypotension
Timepoint
Blood pressure measurement at the beginning of the Study and immediately after the Spinal Anesthesia, every three minutes to 15 minutes and then every five minutes until the End of the Operation.
Method of measurement
Blood pressure Device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ephedrine Group: Five minutes before the Spinal Anesthesia, two ml solution containing 10 mg ephedrine is given intravenously.
Category
Treatment - Drugs
2
Description
Intervention group: ondansetron: Five minutes before spinal anesthesia two ml solution containing 4 mg ondansetron is injected intravenously.
Category
Treatment - Drugs
3
Description
Control group: Five minutes before spinal anesthesia, two ml of distilled water is injected intravenously.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Musavi Hospital
Full name of responsible person
Dr. Vahide Rashtchi
Street address
Musavi Hospital, gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
45139566183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Rashtchi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shoghli
Street address
Azadi Blvd, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3133 0000
Email
RRashtchi@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Sahar Mahmoodi koli
Position
Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No.48, 78 Ave, Islamic Republic Blvd, QomTown
City
Zanjan
Province
Zanjan
Postal code
3716768757
Phone
+98 25 3289 2188
Email
Rashtchi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Vahide Rashtchi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Musavi Hospital, gavazang Avenue
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3133 0000
Email
Rashtchi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sahar Mahmoodi koli
Position
Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No. 48, 78 Ave, Islamic Republic Blvd, Qom Town
City
Zanjan
Province
Zanjan
Postal code
3716768757
Phone
+98 25 3289 2188
Email
Rashtchi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available