- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928601
Norepinephrine Consumption After Prophylactic Ondansetron
August 21, 2017 updated by: Feride Karacaer, Cukurova University
Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse.
If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis.
Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO.
It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia.
The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Adana, Turkey, 01330
- Cukurova University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ASA physical status I-II patients
- Between the ages of 18 and 40 years
- Scheduled for elective caesarean section with spinal anesthesia
Exclusion Criteria:
- History of hypertension
- History of severe hepato-renal disease,
- sensitivity or contraindication to ondansetron,
- Drug or alcohol abuse
- Contraindication to regional anesthesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ondansetron
|
After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.
|
Active Comparator: Saline
|
After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Norepinephrine consumption
Time Frame: During the cesarean operation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bradicardia
Time Frame: During the cesarean operation
|
Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded.
|
During the cesarean operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hakkı Ünlügenç, Professor, Cukurova University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Wang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 10, 2016
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 21, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- NAOS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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