Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial

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

Study Overview

• Status: Completed
• Conditions: Conscious Sedation During Procedure; Endobronchial Ultrasound
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Rescue midazolam; Drug: Fentanyl; Drug: Midazolam bolus; Other: Saline placebo

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 Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160023
    • Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure	Drug: Dexmedetomidine; Dexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure; Drug: Rescue midazolam; Rescue boluses of 0.5 mg midazolam, if needed during procedure; Drug: Fentanyl; 1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
Active Comparator: Midazolam; Midazolam + fentanyl before, and matching saline infusion during, procedure	Drug: Rescue midazolam; Rescue boluses of 0.5 mg midazolam, if needed during procedure; Drug: Fentanyl; 1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure; Drug: Midazolam bolus; Midazolam 2 mg as slow intravenous bolus immediately prior to procedure; Other: Saline placebo; 100 mL saline infusion over 10-15 minutes immediately prior to procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• Kumari R, Jain K, Agarwal R, Dhooria S, Sehgal IS, Aggarwal AN. Fixed dexmedetomidine infusion versus fixed-dose midazolam bolus as primary sedative for maintaining intra-procedural sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a double blind randomized controlled trial. Expert Rev Respir Med. 2021 Dec;15(12):1597-1604. doi: 10.1080/17476348.2021.1918000. Epub 2021 Apr 25.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Bronchoscopy; Sedation; Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Renu1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No