Clinical trial NCT02713191: Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound
Official title: Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Conscious Sedation During Procedure
Endobronchial Ultrasound
Keywords: Bronchoscopy
Sedation
Dexmedetomidine
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-03-18
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two
timeFrame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Secondary outcomes:
measure: Mean difference in depth of sedation during procedure as assessed by Ramsay scale
timeFrame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
measure: Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia
timeFrame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
measure: Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation
timeFrame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
measure: Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale
timeFrame: Immediately after endobronchial ultrasound procedure
measure: Mean difference in time taken to discharge patient from post-procedure recovery room
timeFrame: From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research
Study officials:
References:
citation: 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.