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Completed

NCT Number: NCT02713191

Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research

Chandigarh, 160023, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Midazolam bolus

Drug

Midazolam 2 mg as slow intravenous bolus immediately prior to procedure

Saline Placebo

Other

100 mL saline infusion over 10-15 minutes immediately prior to procedure

Rescue midazolam

Drug

Rescue boluses of 0.5 mg midazolam, if needed during procedure

Fentanyl

Drug

1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure

Primary outcomes

  1. Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two

    Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

Secondary outcomes

  1. Mean difference in depth of sedation during procedure as assessed by Ramsay scale

    Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

  2. Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia

    Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

  3. Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation

    Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours

  4. Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale

    Time frame: Immediately after endobronchial ultrasound procedure

  5. Mean difference in time taken to discharge patient from post-procedure recovery room

    Time frame: From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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