Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation <80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Patras
• Treatments: Dexmedetomidine; Fentanyl; Ketamine; Midazolam

Criteria

Inclusion Criteria:

• Patients scheduled for flexible bronchoscopy at the Naval Hospital of Athens

• Written informed consent

Exclusion Criteria:

• known or suspected allergy to any of the study drugs

• renal impairment (serum creatinine > 2 mg/dL)

• hepatic impairment (liver enzymes > 2 times the upper limit of normal)

• seizure disorders

• history of psychosis or bipolar disorder

• hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg)

• critically ill patients.