Trial · NCT00789815

Bispectral Index-guided Sedation for Flexible Bronchoscopy

NCT00789815, Phase 4, Completed, Chang Gung Memorial Hospital; results first posted 2010-04-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bispectral Index-guided Sedation for Flexible Bronchoscopy. Trials, record NCT00789815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00789815

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bispectral Index-guided Sedation for Flexible Bronchoscopy
NCT number: NCT00789815
Status: Completed
Phases: Phase 4
Enrollment: 500 participants, actual
Lead sponsor: Chang Gung Memorial Hospital
Conditions: Flexible Bronchoscopy
Interventions: Bispectral index guide propofol infusion, Clinical-judged midazolam administration
First posted: 2008-11-13
Last updated: 2017-08-08
Results first posted: 2010-04-20
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy	From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth	The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.
Primary	The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy	From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth	The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.
Primary	The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale	After patients recovered orientation and before they leaved the scope room.	The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).
Secondary	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	"Procedure interference by patients' movement" was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient
Secondary	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	"Procedure interference by cough" was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough.
Secondary	The Recovery Time to Orientation	After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation	The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly
Secondary	The Recovery Time to Ambulation	After the bronchoscopy	The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.
Secondary	Patients Willing Return if Repeated Bronchoscopy is Indicated.	After patients recovered orientation and before they leaved the scope room.	Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both "probably would", and "definitely would return" were defined as patients agreed to return.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy	From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth	Patients completed the whole intervention.	participants	NUMBER
PRIMARY	The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy	From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth	patients completed the whole intervention	participants	NUMBER
SECONDARY	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		participants	NUMBER
SECONDARY	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		participants	NUMBER
SECONDARY	The Recovery Time to Orientation	After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation		minutes	MEAN
PRIMARY	The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale	After patients recovered orientation and before they leaved the scope room.	Patients received intervention completely	units on a scale	MEDIAN
SECONDARY	The Recovery Time to Ambulation	After the bronchoscopy		Minutes	MEAN
SECONDARY	Patients Willing Return if Repeated Bronchoscopy is Indicated.	After patients recovered orientation and before they leaved the scope room.	Patients who answered the question in the questionnaire after bronchoscopy	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy	BIS-guided Propofol Infusion	97		participants
The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy	Clinical-judged Midazolam Administration	88		participants
The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy	BIS-guided Propofol Infusion	18		participants
The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy	Clinical-judged Midazolam Administration	11		participants
The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy	BIS-guided Propofol Infusion	33		participants
The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy	Clinical-judged Midazolam Administration	90		participants
The Number of Participants Causing Any Procedure Interference by Cough	BIS-guided Propofol Infusion	73		participants
The Number of Participants Causing Any Procedure Interference by Cough	Clinical-judged Midazolam Administration	110		participants
The Recovery Time to Orientation	BIS-guided Propofol Infusion	11.7	Standard Deviation 10.2	minutes
The Recovery Time to Orientation	Clinical-judged Midazolam Administration	30.0	Standard Deviation 26.8	minutes

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BIS-guided Propofol Infusion	250
Overall Study	STARTED	Clinical-judged Midazolam Administration	250
Overall Study	COMPLETED	BIS-guided Propofol Infusion	243
Overall Study	COMPLETED	Clinical-judged Midazolam Administration	249
Overall Study	NOT COMPLETED	BIS-guided Propofol Infusion	7
Overall Study	NOT COMPLETED	Clinical-judged Midazolam Administration	1

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypoxemia during flexible bronchoscopy	Respiratory, thoracic and mediastinal disorders	BIS-guided Propofol Infusion	97	250	131
other	Hypoxemia during flexible bronchoscopy	Respiratory, thoracic and mediastinal disorders	Clinical-judged Midazolam Administration	89	250	131
other	Hypotension during flexible bronchoscopy	Cardiac disorders	BIS-guided Propofol Infusion	18	250	37
other	Hypotension during flexible bronchoscopy	Cardiac disorders	Clinical-judged Midazolam Administration	11	250	27
serious	Intubation due to massive bleeding after bronchial biopsy	Respiratory, thoracic and mediastinal disorders	BIS-guided Propofol Infusion	1	250	1
serious	Intubation due to massive bleeding after bronchial biopsy	Respiratory, thoracic and mediastinal disorders	Clinical-judged Midazolam Administration	0	250	0
serious	Pneumothorax	Respiratory, thoracic and mediastinal disorders	BIS-guided Propofol Infusion	1	250	1
serious	Pneumothorax	Respiratory, thoracic and mediastinal disorders	Clinical-judged Midazolam Administration	0	250	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BIS-guided Propofol Infusion
Total, all-cause mortality	Clinical-judged Midazolam Administration
Total, other adverse events	BIS-guided Propofol Infusion	115	250
Total, other adverse events	Clinical-judged Midazolam Administration	100	250
Total, serious adverse events	BIS-guided Propofol Infusion	2	250
Total, serious adverse events	Clinical-judged Midazolam Administration	0	250

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22132138	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy	Trial comparisons
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: Patients Willing Return if Repeated Bronchoscopy is Indicated.	Trial comparisons
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: The Number of Participants Causing Any Procedure Interference by Cough	Trial comparisons
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy	Trial comparisons
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy	Trial comparisons
BIS-guided Propofol Infusion vs Clinical-judged Midazolam Administration: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT00789815/registered

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