Norepinephrine Consumption After Prophylactic Ondansetron
Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?
1 other identifier
interventional
108
1 country
1
Brief Summary
This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 22, 2017
August 1, 2017
9 months
October 6, 2016
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Norepinephrine consumption
Whenever systolic arteriel pressure falls below 100 mmHg or below 20% of the preoperative baseline value in both groups norepinephrine (5 µg) will be administered intravenously and total consumption will be recorded.
During the cesarean operation
Secondary Outcomes (1)
Bradicardia
During the cesarean operation
Study Arms (2)
Ondansetron
EXPERIMENTALSaline
ACTIVE COMPARATORInterventions
After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.
After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.
Eligibility Criteria
You may qualify if:
- ASA physical status I-II patients
- Between the ages of 18 and 40 years
- Scheduled for elective caesarean section with spinal anesthesia
You may not qualify if:
- History of hypertension
- History of severe hepato-renal disease,
- sensitivity or contraindication to ondansetron,
- Drug or alcohol abuse
- Contraindication to regional anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Çukurova University
Adana, 01330, Turkey (Türkiye)
Related Publications (2)
Gao L, Zheng G, Han J, Wang Y, Zheng J. Effects of prophylactic ondansetron on spinal anesthesia-induced hypotension: a meta-analysis. Int J Obstet Anesth. 2015 Nov;24(4):335-43. doi: 10.1016/j.ijoa.2015.08.012. Epub 2015 Aug 22.
PMID: 26421701RESULTWang Q, Zhuo L, Shen MK, Yu YY, Yu JJ, Wang M. Ondansetron preloading with crystalloid infusion reduces maternal hypotension during cesarean delivery. Am J Perinatol. 2014 Nov;31(10):913-22. doi: 10.1055/s-0033-1364189. Epub 2014 Feb 10.
PMID: 24515619RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hakkı Ünlügenç, Professor
Cukurova University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist doctor
Study Record Dates
First Submitted
October 6, 2016
First Posted
October 10, 2016
Study Start
November 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08