Status:
COMPLETED
Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
Lead Sponsor:
University of Virginia
Conditions:
Hypotension
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia. Eighty-six America...
Detailed Description
Over the last 30 years, regional anesthesia has emerged as the method of choice for elective caesarean section because it avoids risks involved in managing the airway of the parturient and has the add...
Eligibility Criteria
Inclusion
- Elective Caesarean section
- Consent to be in the study
- Age 18-45
- ASA 1 or 2
Exclusion
- Patient refusal
- Patients with known allergy to ondansetron will be excluded
- Contraindications to spinal anesthetic
- Known Coagulopathy (acquired e.g. anticoagulation or existing such as liver disease; using patient history, physical examination to determine bleeding risks, a platelet count under 100 or a PT INR over 1.4)
- Severely altered anatomy (e.g. post surgical changes)
- Existing neurological deficits (Women with a history of migraine or tension headache will be allowed to enroll. More severe conditions with daily life limiting symptoms will be excluded. Examples include epilepsy, pseudotumor cerebri, prior stroke with persistent neurologic deficits, or any motor or sensory neuropathy with existing deficits)
- Skin infection overlying site
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01414777
Start Date
November 1 2009
End Date
June 1 2011
Last Update
March 24 2022
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908