Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

Endobronchial Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713191
• Other study ID #: Renu1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 20, 2016
• Last updated: February 16, 2017
• Start date: March 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation During Procedure
• Endobronchial Ultrasound

Intervention

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
• 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

Drug:
• Rescue midazolam
Rescue boluses of 0.5 mg midazolam, if needed during procedure
• Fentanyl
1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure

Locations

Country	Name	City	State
India	Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale		Immediately after endobronchial ultrasound procedure
Secondary	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