The aim of this randomized triple blind clinical trial is prevention of hemodinamic instability with IV ondansetron in spinal Anesthesia in Cesarean section. 80 pregnant woman (18 to 35 years- old) who had singleton term pregnancies in class I physical health classification of the American society of Anesthesia and were candidate for elective cesarean section with spinal anesthesia entered the study.Mothers with a history of hypertension, diabetes, cardiovascular and cerebral diseases, psychosomatic Disorder, known fetal anomaly, any kind of contraindications for spinal anesthesia were excluded. Mothers with weight more than 100 kg or height less than 150 cm were also excluded. Using random numbers table, mothers were divided into two groups. For All the mothers, 500 cc of Ringer or NS Serum infused before Spinal anesthesia (in group one, 4 mg ondansetron Injected through IV line and in group two, same volume of placebo (instilled water) was injected. Then mothers received 10 mg of bupivacaine 0.5% intrathecally after Spinal anesthesia. HR and BP were measured every 2 min and compared in two groups. Also vomiting and Nausea in two groups were evaluated and compared. Total dose of Atropine and ephedrine in mothers and PH, lactate, Base Excess and Apgar in neonate were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706015381N12
Registration date:2017-06-21, 1396/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chacellor research for Babol University Of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intravenous ondansetron in preventing hypotension in patients undergoing elective cesarean section
Public title
The Effect Of Ondansetron on maternal hypotension prevention during elective cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women (18 to 35 years old) Candidate for elective cesarean section, In class I physical health classification of the American Society of Anesthesia. All women had singleton term pregnancies.
Exclusion Criteria: Mothers with a history of hypertension؛ Diabetes؛ cardiovascular and cerebral diseases؛ known fetal anomaly؛ any kind of contraindications for spinal anesthesia؛ psychosomatic Disorder؛ Patients weighting over 100 Kg and Height less than 150 cm and those with difficult tracheal intubation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
All Patients by using random numbers, they were divided into two groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Postal code
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
MUBABOL.REC.1395.148
Health conditions studied
1
Description of health condition studied
Maternal hypotension
ICD-10 code
O26.5
ICD-10 code description
Maternal hypotension syndrome
Primary outcomes
1
Description
Maternal blood presure
Timepoint
Maternal blood pressure was monitored and recorded every two minutes for the first 15 minutes following spinal anesthesia, and then every 5 minutes until completion of surgery.
Method of measurement
Non invasive blood presure cuff
Secondary outcomes
1
Description
Maternal heart rate
Timepoint
during surgery
Method of measurement
With cardiac monitoring and heart rate
2
Description
Neonatal arterial blood gas
Timepoint
After Surgery
Method of measurement
Arterial blood gas samples
3
Description
Neonatal apgar score
Timepoint
1 and 5 minutes after surgery.
Method of measurement
Cheklist/ examination/ observation
Intervention groups
1
Description
Control group: 2 mm distilled water was injected intravenously before spinal anesthesia
Category
Prevention
2
Description
Intervention group: 4 mg ondansetron ( Norman/Italy) was injected intravenously before spinal anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital of Babol
Full name of responsible person
Dr Nadia Banihashem
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor research for Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Babol University Of Medical Sciences, Ganjafrooz street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor research for Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Nadia Banihashem
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr.Nadia Banihashem
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr. Nadia Banihashem
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
nbanihashem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)