NCT02713191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 20, 2016

Last Update Submit

February 16, 2017

Conditions

Conscious Sedation During ProcedureEndobronchial Ultrasound

Keywords

BronchoscopySedationDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure

Drug: DexmedetomidineDrug: Rescue midazolamDrug: Fentanyl

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam bolusOther: Saline placeboDrug: Rescue midazolamDrug: Fentanyl

Interventions

DexmedetomidineDRUG

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

Dexmedetomidine
Midazolam bolusDRUG

Midazolam 2 mg as slow intravenous bolus immediately prior to procedure

Midazolam
Saline placeboOTHER

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

Midazolam
Rescue midazolamDRUG

Rescue boluses of 0.5 mg midazolam, if needed during procedure

DexmedetomidineMidazolam
FentanylDRUG

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

DexmedetomidineMidazolam

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chandigarh, Chandigarh, 160023, India

Location

Related Publications (1)

  • 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.

    PMID: 33849367DERIVED

MeSH Terms

Interventions

DexmedetomidineFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pulmonary Medicine

Study Record Dates

First Submitted

January 20, 2016

First Posted

March 18, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

IN(1)