Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Conscious Sedation During Procedure; Endobronchial Ultrasound

Treatments: Drug: Rescue midazolam; Other: Saline placebo; Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Midazolam bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT02713191

Renu1

Details and patient eligibility

About

The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound

Full description

Benzodiazepines, opioids, and propofol are currently used alone or in combination for achieving sedation during endobronchial ultrasound and other bronchoscopic procedures. However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not cause respiratory depression. This study aims to compare efficacy and safety of dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior to procedure, followed by dexmedetomidine or saline infusion respectively during the procedure. Ramsay sedation score of two will be targeted, failing which patients in both groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the procedure will be compared between the two groups.

Enrollment: 197 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or more
• American Society of Anesthesiologists physical status I or II
• Presence of hilar and/or mediastinal lymph nodes on thoracic CT scan

Exclusion criteria

• Known allergy to dexmedetomidine or midazolam or fentanyl
• Documented coagulopathy
• Pregnancy
• Hemodynamic instability (hypotension, arrhythmia, recent acute coronary event)
• Neuropsychiatric illness
• History of previous endobronchial ultrasound procedure
• Refusal to provide consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups

Dexmedetomidine

Experimental group

Description:

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

Treatment:

Drug: Dexmedetomidine

Drug: Fentanyl

Drug: Rescue midazolam

Midazolam

Active Comparator group

Description:

Midazolam + fentanyl before, and matching saline infusion during, procedure

Treatment:

Drug: Midazolam bolus

Drug: Fentanyl

Other: Saline placebo

Drug: Rescue midazolam