CompletedPhase 3ketamine

Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

Sponsored by University of Patras

NCT ID
NCT06185127
Target Enrollment
50 participants
Start Date
2019-09-01
Est. Completion
2020-08-31

About This Study

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.

Conditions Studied

Lung DiseasesDiagnosisAnesthesia

Interventions

  • Dexmedetomidine
  • Ketamine
  • Midazolam
  • Fentanyl

Eligibility

Age:19 Years - 90 Years
Healthy Volunteers:No
View full eligibility 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.

Study Locations (1)

Naval Hospital
Athens, Attica, Greece

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source