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NCT06181188 · ClinicalTrials.gov registry record · Phase 4
Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy
A Phase 4 study, sponsored by Brooke Army Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT06181188 is a Phase 4 study that has completed, run by Brooke Army Medical Center. The registered enrollment target is 66 participants.
The verdict
NCT06181188, a Phase 4 study, has completed, sponsored by Brooke Army Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either 1 mg of midazolam and ketamine 0.25 to 0.5 mg/kg loading dose with subsequent doses of 10-20 mg IV or standard fentanyl and midazolam in 25mcg and 1mg increments respectively for moderate sedation during their procedure. The primary outcome will be patient satisfaction, which will be measured a using patient clinical satisfaction form. A number of secondary outcomes will include the following: (1) provider satisfaction (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to scope removal from the trachea (4) the time from sedation to discharge (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (5) total dose of medications given (including midazolam, fentanyl, and ketamine), (6) adverse events, (7) vital signs, (8) and the need for additional medications, in particular reversal agents.
Interventions
- DRUG Ketamine
- DRUG Midazolam
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06181188
The ClinicalTrials.gov registry entry for NCT06181188 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brooke Army Medical Center, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ketamine is the first listed.
NCT06181188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06181188 about?
NCT06181188 is a clinical study titled "Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy". In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, w...
What is the current status of trial NCT06181188?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2019-07-15. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT06181188?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT06181188?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
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