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Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound

NCT02713191 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2017-02-17

No results posted yet for this study

Summary

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

Conditions

  • Conscious Sedation During Procedure
  • Endobronchial Ultrasound

Interventions

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

DRUG

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

DRUG

Fentanyl

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713191 on ClinicalTrials.gov