Flexible BronchoscopyPhase 4NCT00789815
Bispectral Index-guided Sedation for Flexible Bronchoscopy
A Phase 4 study testing Bispectral index guide propofol infusion and Clinical-judged midazolam administration in people with Flexible Bronchoscopy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexible Bronchoscopy
- What is being tested?
- Bispectral index guide propofol infusion and Clinical-judged midazolam administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (>18 years old) requiring elective flexible bronchoscopy or Real time endobronchial ultrasound with transbronchial needle aspiration.
Who cannot join
- American Society of Anesthesiologists classification of physical status 4 and 5, including hepatic or renal failure, severe obstructive sleep apnea and severe chronic obstructive pulmonary disease.
- Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
- Allergic history to study drugs.
- A history of glaucoma in the midazolam arm.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan City, 333
About this study
Official title: Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-guided Sedation and Conventional Sedation
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.
Read the detailed description
It is well known that patients undergoing bronchoscopy could be less suffering and the procedures could be carried on more smoothly if the patients have adequate sedation and analgesia. The preferred sedative and analgesic drugs are Midazolam and opioid, like Alfentanil or Morphine, which were titrated according to physicians' judgment on patients' clinical responsiveness. However, due to the pharmacokinetic characteristic of midazolam while used in intravenous injection (onset time 4-6 minutes, effective time 2-4 hours), the effective onset time may be too slow for repeated injection while patients already suffered from the bronchoscopic procedure. It is also noted that when over-sedation occurred the side effects like apnea/hypopnea, hypoxemia, and hypotension could last from dozen minutes to few hours. Although events mentioned above could be handled properly under experienced medical staff, it is still very difficult to predict the oncoming events as the pharmacokinetic effect is variant individually. Ideally, it will be more safe and efficient, during invasive procedure like bronchoscope, if the sedative drug could be onset or vanish fast and the drug effect could be titrated with an objective device directly monitoring the depth of sedation or anesthesia.
Propofol is a short-acting intravenous sedative agent used for the induction of general anesthesia for children and adults; maintenance of general anesthesia; and sedation in medical contexts, such as intensive care unit (ICU) sedation for intubated, mechanically ventilated adults, and in procedures such as colonoscopy. Its mechanism of action is uncertain, but it is postulated that its primary effect may be potentiation of the Gamma-Amino Butyric Acid-A receptor, possibly by slowing the channel closing time. It has a fast onset time (1~2 minutes) but a short working duration (8~10 minutes), which vanished fast after stop administration. Bispectral Index (BIS), an non-invasive neurophysiologic monitor instrument, can transform the electroencephalogram (EEG) and electromyography of the patient to a continual numeral, ranging from 0 to 99, which provides a direct and real-time sedative depth monitor. A BIS value of 0 equals EEG silence, near 100 is the expected value in a fully awake adult, and below70 indicated the patient lose explicit memory recall but still has the ability to maintain his own vital signs.
In this study, we design a sedative technique for bronchoscopy, a BIS-guided propofol administration, to compare with the traditional sedative technique, clinical-judged midazolam administration. Through the combination of the advantages of unique pharmacokinetics of propofol and real time monitor of sedative level from BIS, we hope to provide patients undergoing bronchoscopy a more satisfied and safety sedative procedure.
- Conditions
- Flexible Bronchoscopy
- Being tested
- Bispectral index guide propofol infusion, Clinical-judged midazolam administration
- Keywords
- flexible bronchoscopy, sedation, bispectral index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index guide propofol infusionDevice
Also called BIS-guided profopol infusion
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.
| Study group | Role | What they receive |
|---|---|---|
| BIS-guided propofol infusion | Active comparator | 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. Receives: Device: Bispectral index guide propofol infusion |
| Clinical-judged midazolam administration | Active comparator | 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 Receives: Drug: Clinical-judged midazolam administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: After patients recovered orientation and before they leaved the scope room.
Secondary outcomes (5)
The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy
"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
Measured: 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
"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.
Measured: 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
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
Measured: After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation
The Recovery Time to Ambulation
The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.
Measured: After the bronchoscopy
Patients Willing Return if Repeated Bronchoscopy is Indicated.
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.
Measured: After patients recovered orientation and before they leaved the scope room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flexible BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ting-Yu Lin, MD, Principal investigator, Division of Thoracic Medicine, Chang Gung Memorial hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789815
- Sponsor's protocol ID
- 97-0257B
- Status last verified
- Apr 2010
- First submitted
- 10 Nov 2008
- Last updated
- 8 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22132138
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-guided Sedation and Conventional Sedation
- ClinicalTrials.gov ID
- NCT00789815
- Acronym / sponsor ID
- 97-0257B
- Conditions
- Flexible Bronchoscopy
- Keywords
- flexible bronchoscopy, sedation, bispectral index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 20 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is well known that patients undergoing bronchoscopy could be less suffering and the procedures could be carried on more smoothly if the patients have adequate sedation and analgesia. The preferred sedative and analgesic drugs are Midazolam and opioid, like Alfentanil or Morphine, which were titrated according to physicians' judgment on patients' clinical responsiveness. However, due to the pharmacokinetic characteristic of midazolam while used in intravenous injection (onset time 4-6 minutes, effective time 2-4 hours), the effective onset time may be too slow for repeated injection while patients already suffered from the bronchoscopic procedure. It is also noted that when over-sedation occurred the side effects like apnea/hypopnea, hypoxemia, and hypotension could last from dozen minutes to few hours. Although events mentioned above could be handled properly under experienced medical staff, it is still very difficult to predict the oncoming events as the pharmacokinetic effect is variant individually. Ideally, it will be more safe and efficient, during invasive procedure like bronchoscope, if the sedative drug could be onset or vanish fast and the drug effect could be titrated with an objective device directly monitoring the depth of sedation or anesthesia.
Propofol is a short-acting intravenous sedative agent used for the induction of general anesthesia for children and adults; maintenance of general anesthesia; and sedation in medical contexts, such as intensive care unit (ICU) sedation for intubated, mechanically ventilated adults, and in procedures such as colonoscopy. Its mechanism of action is uncertain, but it is postulated that its primary effect may be potentiation of the Gamma-Amino Butyric Acid-A receptor, possibly by slowing the channel closing time. It has a fast onset time (1~2 minutes) but a short working duration (8~10 minutes), which vanished fast after stop administration. Bispectral Index (BIS), an non-invasive neurophysiologic monitor instrument, can transform the electroencephalogram (EEG) and electromyography of the patient to a continual numeral, ranging from 0 to 99, which provides a direct and real-time sedative depth monitor. A BIS value of 0 equals EEG silence, near 100 is the expected value in a fully awake adult, and below70 indicated the patient lose explicit memory recall but still has the ability to maintain his own vital signs.
In this study, we design a sedative technique for bronchoscopy, a BIS-guided propofol administration, to compare with the traditional sedative technique, clinical-judged midazolam administration. Through the combination of the advantages of unique pharmacokinetics of propofol and real time monitor of sedative level from BIS, we hope to provide patients undergoing bronchoscopy a more satisfied and safety sedative procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS-guided propofol infusion | Active comparator | Device: Bispectral index guide propofol infusionIn 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 | Active comparator | Drug: Clinical-judged midazolam administrationIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (>18 years old) requiring elective flexible bronchoscopy or Real time endobronchial ultrasound with transbronchial needle aspiration.
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists classification of physical status 4 and 5, including hepatic or renal failure, severe obstructive sleep apnea and severe chronic obstructive pulmonary disease.
- Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
- Allergic history to study drugs.
- A history of glaucoma in the midazolam arm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral index guide propofol infusionAlso: BIS-guided profopol infusionInduction: 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. | Device | BIS-guided propofol infusion |
| Clinical-judged midazolam administrationInduction: 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. | Drug | Clinical-judged midazolam administration |
Primary outcome
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
The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.
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
The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.
The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale
Time frame: 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).
5 secondary outcomes
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
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
The Recovery Time to Orientation
Time frame: After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation
The Recovery Time to Ambulation
Time frame: After the bronchoscopy
Patients Willing Return if Repeated Bronchoscopy is Indicated.
Time frame: After patients recovered orientation and before they leaved the scope room.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22132138Lo 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.
Related trials for Flexible Bronchoscopy
Not yet recruiting
Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy
Active, not recruiting
the Value of Flexible Bronchoscopy in the Neonatal Intensive Care Unit at Sohag University Hospitals
Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting-Yu Lin, MD principal investigator
Division of Thoracic Medicine, Chang Gung Memorial hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bispectral index guide propofol infusion and Clinical-judged midazolam administration in people with Flexible Bronchoscopy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017; AzTrials last refreshed its copy on 31 Oct 2026.