At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 500 enrolled

Drug / intervention

Clinical-judged midazolam administration +1 moredrug

Likely dose

Clinical-judged midazolam administration 5μgfrom 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/NCT00789815

NCT00789815Phase 4Completed

Compare CT.gov

Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-guided Sedation and Conventional Sedation

Chang Gung Memorial Hospital·interventional·Posted Nov 13, 2008·Updated Aug 8, 2017

In Brief

A Phase 4 clinical trial evaluating Bispectral index guide propofol infusion and Clinical-judged midazolam administration for Flexible Bronchoscopy. Completed, enrolled 500 participants across 1 site.

Detailed Summary

With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time endobronchial ultrasound, the complexity and duration of procedures are increasing. So, adequate sedation and analgesia is important for both patients and bronchoscopist. Clinical-judged midazolam administration is the current standard. However, midazolam is difficult to titrated and the clinical observations are not reliable sedative indices. Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a real time monitor of depth-of-sedation, has been applied in general anesthesia. We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of advantages of propofol and BIS, we hope to provide patients a more tolerable and safety sedation for bronchoscopy.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFlexible Bronchoscopy

CountriesTaiwan

Collaborators--

Timeline

Phase 4CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2008

First PostedNov 2008

Primary CompletionSep 2009

TodayJul 2026

First PostedNov 13, 2008

Enrollment StartApr 1, 2008

Primary CompletionSep 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 17.6 years ago

Interventions

Bispectral index guide propofol infusiondevice

Induction: Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70. Maintenance: Propofol infusion (3\~12 mg/kg/hour) to maintain BIS around 65\~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough.

Clinical-judged midazolam administrationdrug

Induction: Alfentanil: 5μg/kg slowly push. Midazolam: 2 mg slowly push followed by increments of 2 mg/ 2min till OAA/S\* 2\~3. Maintenance: Midazolam: 2 mg/ 2min prn to keep OAA/S\* 2\~3 or if intolerance of procedure. Alfentanil as study arm. \*Observer's assessment of alertness/sedation (OAA/S): Class 5: Responds readily to name spoken in normal tone. Class 4: Lethargic response to name called in normal tone. Class 3: Responds only to name called loudly. Class 2: Responds only to shaking. Class 1: No response to shaking.