Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00334360 · ClinicalTrials.gov registry record · Phase 4
Dexmed/Buspirone Synergism on Shivering
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT00334360 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 8 participants.
The verdict
NCT00334360, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration. Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.
Interventions
- DRUG Control
- DRUG dexmedetomidine
- DRUG buspirone
- DRUG Bus and Dex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00334360
The ClinicalTrials.gov registry entry for NCT00334360 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Control is the first listed.
NCT00334360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00334360 about?
NCT00334360 is a clinical study titled "Dexmed/Buspirone Synergism on Shivering". The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg o...
What is the current status of trial NCT00334360?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2004-09. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00334360?
The interventions under investigation include: Control (DRUG), dexmedetomidine (DRUG), buspirone (DRUG), Bus and Dex (DRUG).
Who is sponsoring clinical trial NCT00334360?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.