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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: Completed Phase 2 study, sponsored by University of Virginia.
NCT01414777 is a Phase 2 study that has completed, run by University of Virginia. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
hypotension \& bradycardia will be recorded from the placement of the spinal through the end of surgical c-section
Interventions
- DRUG placebo
- DRUG ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01414777 record still lists
NCT01414777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01414777 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01414777's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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