Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy
Completed · Phase 4
Conditions studied: Conscious Sedation, Patient Satisfaction, Ketamine
In brief
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.
Key facts
- Study ID
- NCT06181188
- Run by
- Brooke Army Medical Center
- People needed
- 66
- Starts
- 2019-07-15
- Expected to finish
- 2023-10-30
- Last updated by the study team
- 2023-12-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients age 18 to 75 years who present to the pulmonary clinic for bronchoscopy and considered for airway survey, transbronchial biopsy, endobronchial biopsy, or bronchoalveolar lavage.
- Provider performing the bronchoscopy
You may not qualify if…
- Systolic blood pressure over 180mmHg and/or diastolic blood pressure over 110 on two consecutive readings
- Tachycardia greater than 120 beats/minute on two consecutive measurements
- Any allergy to ketamine, fentanyl, or midazolam
- Patient is pregnant or refuses pregnancy test,in women of child-bearing potential*
- American Society of Anesthesiologists (ASA) score > 3
- Presence of a history of psychosis, hallucinations, and/or a psychotic disorder
Where it is running
- Brooke Army Medical Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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