Sponsor study identifier
interventional
500
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
September 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 10, 2008
Actual (reported)November 13, 2008
Actual (reported)September 2009
Actual (reported)September 2009
Actual (reported)April 20, 2010
Actual (reported)The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy
The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.
From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy
The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.
From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale
The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).
After patients recovered orientation and before they leaved the scope room.
The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy
From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The Number of Participants Causing Any Procedure Interference by Cough
From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The Recovery Time to Orientation
After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation
The Recovery Time to Ambulation
After the bronchoscopy
Patients Willing Return if Repeated Bronchoscopy is Indicated.
After patients recovered orientation and before they leaved the scope room.
In the study group, induction was started using alfentanil 4\~5μg/kg bolus following repeated propofol boluses (0.5\~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3\~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
In the control group, induction was started using alfentanil 4\~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/2min until conscious sedation was achieved
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.
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan City, 333, Taiwan
Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
The bronchoscopists were not blinded to sedative procedures. It was difficult to accomplish totally blind conditions. The bronchoscopist would realize which protocol it was when only observing responses of the investigator.
Ting-Yu Lin, MD
Division of Thoracic Medicine, Chang Gung Memorial hospital
500 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2008
First Posted
November 13, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
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.
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Primary Completion
September 2009
Actual (reported)Study Completion
September 2009
Actual (reported)Last Updated
August 8, 2017
Results First Posted
April 20, 2010
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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