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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02713191
Other study ID # Renu1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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