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NCT01414777 · ClinicalTrials.gov registry record · Phase 2
Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
A Phase 2 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT01414777 is a Phase 2 study that has completed, run by University of Virginia. The registered enrollment target is 68 participants.
The verdict
NCT01414777, a Phase 2 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study 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 American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled. Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug. Baseline measurements of vital signs will be taken. Otherwise standard management will then be used: * Patients must be NPO for 8 hours * Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider. * Standard lumbar puncture in a sitting position the L3-L4 or L4-L5 * Whitacre pencil-point, 25 gauge * Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl * Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh \[only knee/feet\]; 2, inability to flex the knee \[only feet\]; 3, inability to move any joint in the legs).
Interventions
- DRUG placebo
- DRUG ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01414777
The ClinicalTrials.gov registry entry for NCT01414777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01414777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01414777 about?
NCT01414777 is a clinical study titled "Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients". 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 American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, par...
What is the current status of trial NCT01414777?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2009-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01414777?
The interventions under investigation include: placebo (DRUG), ondansetron (DRUG).
Who is sponsoring clinical trial NCT01414777?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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