Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Phase 2

Completed

• Conditions: Conscious Sedation During Procedure; Endobronchial Ultrasound
• Interventions: Drug: Midazolam bolus; Drug: Dexmedetomidine; Drug: Rescue midazolam; Other: Saline placebo; Drug: Fentanyl

• Registration Number: NCT02713191
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-01-20
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Status Verified: 2017-02
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Rescue midazolam	Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure
Midazolam	Midazolam bolus	Midazolam + fentanyl before, and matching saline infusion during, procedure
Midazolam	Saline placebo	Midazolam + fentanyl before, and matching saline infusion during, procedure
Midazolam	Rescue midazolam	Midazolam + fentanyl before, and matching saline infusion during, procedure
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure
Dexmedetomidine	Fentanyl	Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure
Midazolam	Fentanyl	Midazolam + fentanyl before, and matching saline infusion during, procedure

Primary Outcome Measures

Name	Time	Method
Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two	From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

Secondary Outcome Measures

Name	Time	Method
Mean difference in depth of sedation during procedure as assessed by Ramsay scale	From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Mean difference in time taken to discharge patient from post-procedure recovery room	From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours
Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia	From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation	From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale	Immediately after endobronchial ultrasound procedure

Trial Locations

Locations (1)

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India