Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial

NCT03613792 Phase 4 WITHDRAWN

This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.

Details

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	Phase 4
Status	WITHDRAWN
Start date	2023-09
Completion	2023-12

Conditions

• Bronchoscopy

Interventions

• Remifentanil
• Fentanyl
• Midazolam
• Ketamine

Primary outcomes

• Patient Satisfaction with Sedation Instrument (PSSI) — Two hours after procedure conclusion, prior to patient discharge from the hospital
  The primary outcome will be a difference in patient satisfaction with sedation, as determined by a 5-point difference in the PSSI questionnaire. The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).

Countries

United States