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Bispectral Index-guided Sedation for Flexible Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00789815
First received: November 10, 2008
Last updated: April 1, 2010
Last verified: April 2010
History of Changes
Results First Received: February 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Flexible Bronchoscopy
Interventions: Device: Bispectral index guide propofol infusion
Drug: Clinical-judged midazolam administration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The investigator evaluate the inclusion and exclusion criteria of patients undergoing flexible bronchoscopy (FB) at the bronchoscopic room. If patients were eligible, investigator would explain the informed concent, the safety managements and the way of sedation and FB to patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If patients or family refused to join the study later or if the intravenous catheter was difficultly placed on the forearm, patients were excluded before assignment.

Reporting Groups
  Description
BIS-guided Propofol Infusion 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.
Clinical-judged Midazolam Administration 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/min until conscious sedation was achieved

Participant Flow:   Overall Study
    BIS-guided Propofol Infusion     Clinical-judged Midazolam Administration  
STARTED     250     250  
COMPLETED     243     249  
NOT COMPLETED     7     1  
Protocol Violation                 6                 1  
Intubation due to massive bleeding                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
BIS-guided Propofol Infusion 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.
Clinical-judged Midazolam Administration 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/min until conscious sedation was achieved
Total Total of all reporting groups

Baseline Measures
    BIS-guided Propofol Infusion     Clinical-judged Midazolam Administration     Total  
Number of Participants  
[units: participants]
 		  250     250     500  
Age  
[units: participants]
 		     
<=18 years     0     1     1  
Between 18 and 65 years     144     124     268  
>=65 years     106     125     231  
Age  
[units: years]
Mean ± Standard Deviation 		  59.9  ± 13.1     62.0  ± 14.7     60.9  ± 14.0  
Gender  
[units: participants]
 		     
Female     102     111     213  
Male     148     139     287  
Region of Enrollment  
[units: participants]
 		     
Taiwan     250     250     500  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy   [ Time Frame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth ]
  Show Outcome Measure 1

2.  Primary:   The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy   [ Time Frame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth ]
  Show Outcome Measure 2

3.  Primary:   The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale   [ Time Frame: After patients recovered orientation and before they leaved the scope room. ]
  Show Outcome Measure 3

4.  Secondary:   The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy   [ Time Frame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth ]
  Show Outcome Measure 4

5.  Secondary:   The Number of Participants Causing Any Procedure Interference by Cough   [ Time Frame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth ]
  Show Outcome Measure 5

6.  Secondary:   The Recovery Time to Orientation   [ Time Frame: After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation ]
  Show Outcome Measure 6

7.  Secondary:   The Recovery Time to Ambulation   [ Time Frame: After the bronchoscopy ]
  Show Outcome Measure 7

8.  Secondary:   Patients Willing Return if Repeated Bronchoscopy is Indicated.   [ Time Frame: After patients recovered orientation and before they leaved the scope room. ]
  Show Outcome Measure 8


  Serious Adverse Events
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Time Frame During bronchoscopy and after recovery within 3 days.
Additional Description The adverse events is the primary outcome of this study. So, regular assessment would be done during bronchoscopy and after recovery. In this study, all adverse events recovered spontaneously or after proper managements.

Reporting Groups
  Description
BIS-guided Propofol Infusion 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.
Clinical-judged Midazolam Administration 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/min until conscious sedation was achieved

Serious Adverse Events
    BIS-guided Propofol Infusion     Clinical-judged Midazolam Administration  
Total, serious adverse events      
# participants affected / at risk     2/250 (0.80%)     0/250 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Intubation due to massive bleeding after bronchial biopsy † [2]    
# participants affected / at risk     1/250 (0.40%)     0/250 (0.00%)  
# events     1     0  
Pneumothorax † [3]    
# participants affected / at risk     1/250 (0.40%)     0/250 (0.00%)  
# events     1     0  
† Events were collected by systematic assessment
[2] Bleeding from the biopsy site is the risk of bronchial biospy. After intubation, the patient was stabilized. He recovered later and discharged without sequelae.
[3] Pneumothorax is the risk of transbronchial lung biopsy. After chest tube draining, the patient recovered and discharged without any sequelae.




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Ting-Yu Lin
Organization: Chung Gung Memorial Hospital
phone: 886 3 3281200 ext 5108
e-mail: yuebaoyuebao@yahoo.com.tw


No publications provided by Chang Gung Memorial Hospital

Publications automatically indexed to this study:


Responsible Party: Ting-Yu Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00789815     History of Changes
Other Study ID Numbers: 97-0257B
Study First Received: November 10, 2008
Results First Received: February 3, 2010
Last Updated: April 1, 2010
Health Authority: Taiwan: Institutional Review Board