The effectiveness of ondansetron on hemodynamic changes following spinal anesthesia in pregnant women and comparison with prehydration and prophylactic ephedrine
Purpose of the study: the effectiveness of ondansetron on hemodynamic changes following spinal anesthesia in pregnant women and its comparison with prehydration and prophylactic ephedrine. Design: single-blind, randomized, blocking study. Samples were divided into four groups using randomized block design.
Study population: pregnant women aged between 18 and 40 years undergoing cesarean section.
Inclusion criteria: ASA I and ASA II diseases; aged between 18 and 40 years; single or twin gestations; undergoing Cesarean section or spinal anaesthesia for emergency Caesarean; not using anti-migraine therapeutics, SSRI or MAO inhibitors; not being allergic to ondansetron; absence of psychological disorders; and not consuming drugs or alcohol.
Exclusion criteria: Failure of spinal anesthesia; untreatable pain with 50 micrograms of fentanyl after the onset of surgery; bleeding more than expected (500 cc in single gestation and 1000 cc in twin gestations); numbness extending beyond the dermatome T4 level according to skin testing with needle point; need to expand incision during surgery due to the surgical complications; and having major complications during surgery.
Sample: 120.
Study Intervention: ondansetron, ephedrine and ringer.
Time of intervention: during anesthesia for cesarean
The outcome of the study: Clinical information of patients will be recorded when they enter the operating room. Maternal blood pressure, ECG and heart rate are recorded before and after the anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102813159N7
Registration date:2016-01-21, 1394/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-21, 1394/11/01
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of ondansetron on hemodynamic changes following spinal anesthesia in pregnant women and comparison with prehydration and prophylactic ephedrine
Public title
The effectiveness of ondansetron on pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I and ASA II diseases; aged between 18 and 40 years; single or twin gestations; undergoing Cesarean section or spinal anaesthesia for emergency Caesarean; not using anti-migraine therapeutics, SSRI or MAO inhibitors; not being allergic to ondansetron; absence of psychological disorders; and not consuming drugs or alcohol.
Exclusion criteria: Failure of spinal anesthesia; untreatable pain with 50 micrograms of fentanyl after the onset of surgery; bleeding more than expected (500 cc in single gestation and 1000 cc in twin gestations); numbness extending beyond the dermatome T4 level according to skin testing with needle point; need to expand incision during surgery due to the surgical complications; and having major complications during surgery.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2015-07-22, 1394/04/31
Ethics committee reference number
IR.mums.FM.REC.1394.208
Health conditions studied
1
Description of health condition studied
pregnant women
ICD-10 code
O82.8
ICD-10 code description
Other single delivery by caesarean section
Primary outcomes
1
Description
Maternal blood pressure
Timepoint
Before and after anesthesia
Method of measurement
Clinical mercury Manometer; mmHg
Secondary outcomes
1
Description
Maternal heart rate
Timepoint
Before and after anesthesia
Method of measurement
Monitoring Compact; in minuets
Intervention groups
1
Description
Control group: 4 mg of placebo drugs 5 minutes before spinal anesthesia
Category
Treatment - Drugs
2
Description
Intervention group 1: 4 mg of Ondansetron 5 minutes before spinal anesthesia.
Category
Treatment - Drugs
3
Description
Intervention group 2: 25 mg of Ephedrine injection to the muscle 25 minutes before spinal anesthesia
Category
Treatment - Drugs
4
Description
Intervention group 3: 500 ml of Ringer 20 minutes before spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem Hospital, Ahmadabad Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences