Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

NCT ID: NCT02713191

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-02-01

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.

Conditions

Conscious Sedation During Procedure; Endobronchial Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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

Rescue midazolam

Intervention Type: DRUG

Rescue boluses of 0.5 mg midazolam, if needed during procedure

Fentanyl

Intervention Type: DRUG

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

Midazolam

Midazolam + fentanyl before, and matching saline infusion during, procedure

Group Type: ACTIVE_COMPARATOR

Midazolam bolus

Intervention Type: DRUG

Midazolam 2 mg as slow intravenous bolus immediately prior to procedure

Saline placebo

Intervention Type: OTHER

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

Rescue midazolam

Intervention Type: DRUG

Rescue boluses of 0.5 mg midazolam, if needed during procedure

Fentanyl

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Midazolam bolus

Midazolam 2 mg as slow intravenous bolus immediately prior to procedure

Intervention Type: DRUG

Saline placebo

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

Intervention Type: OTHER

Rescue midazolam

Rescue boluses of 0.5 mg midazolam, if needed during procedure

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ashutosh Nath Aggarwal

Professor of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chandigarh, Chandigarh, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 33849367 (View on PubMed)

Other Identifiers

Renu1

Identifier Type: -

Identifier Source: org_study_id