CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Dexmedetomidine arm +1 moredrug
Likely dose
Dexmedetomidine arm 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03521505
NCT03521505Phase 4Completed

Dexmedetomidine and Brain Perfusion Monitor for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Chang Gung Memorial Hospital·interventional·Posted May 11, 2018·Updated Sep 9, 2021

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine arm and Propofol arm for Bronchoscopy. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation. Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. In the preset study, we evaluate the safety and feasibility of the Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchoscopy
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 11, 2018
Enrollment StartMay 11, 2018
Primary CompletionJan 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.1 years ago

Interventions

Dexmedetomidine armdrug

Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5\~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3\~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration

Propofol armdrug

5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3\~2. Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 \< 90%) or hypotension (mean arterial pressure (MAP) \< 65 mmHg, or systolic blood pressure (SBP) \< 90 mmHg) in any duration.