Flexible BronchoscopyNCT01101477

Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

A study testing TCI titration by different Cet. in people with Flexible Bronchoscopy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Flexible Bronchoscopy
What is being tested?: TCI titration by different Cet.
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteTaiwan
Study dates: Feb 2010to Aug 2010
Phase: Interventional
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 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (18 years old or more) required elective flexible bronchoscopy and sedation.

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.
Mallampati score 4 or 5.
Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
Men with body mass index(BMI) large than 42，Females with BMI large than 35.
Allergic history to study drugs.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation: Determining the Optimal Titrating Regimen

Flexible bronchoscopy (FB) sedation requires keeping sedative level in a narrow window to prevent over or under sedation. Sedative drug titration according to subjective adjustment by individual physician may cause unsteady drug concentration. Target controlled infusion (TCI) has been provided a precise pharmacokinetic control of propofol, direct control the effect side, (eg. Brain) concentration (Ce), and been applied in surgical anesthesia and variable procedure sedation. We designed this pilot study to evaluate the optimal regimen of TCI in FB sedation.

Read the detailed description

Propofol is ideal for bronchoscopy sedation because of its fast onset and quick recovery effect. Our research and reports from different investigators demonstrate that patients received propofol sedation recover fast with excellent satisfaction for bronchoscopy. However, the amount of propofol for induction and maintenance is calculated simply by patient's body weight and physicians' experience. For those non-anesthesiologists, who perform sedative work outside the operating room, and inexperienced anesthesiologist without fully considering the individual pharmacokinetic and pharmacodynamic differences may generate unstable drug plasma concentration and increase cardio-respiration suppression. Therefore, a manner which can assess and measure objectively individual pharmacokinetic differences may improve the sedative quality and decrease the complication rate.

A model called "Target-controlled infusion"(TCI), built from massive pharmacokinetic samples of propofol, could now give precise pharmacokinetic control. Several pharmacokinetic models built-in in TCI, includes the Schnider model which use concentration of effect site (Ce, the propofol concentration in the brain) as the sedative guide. The model integrates individual variants of age, height, weight and gender to calculate the infusion profile to achieve predetermined steady "target effect site concentration" (Cet). Because of the unique consideration of individual pharmacokinetic variants and Ce targeting, TCI provides predictable sedative level and is suitable for procedures requiring narrowing therapeutic level. Beside general anesthesia, TCI has been applied in breast biopsy, upper gastrointestinal endoscopic ultrasound and endoscopic retrograde cholangiopancreatography at outpatient clinic. According to these evidences, there is potential role of TCI in bronchoscopic sedation.

Based on current evidence and our experience, we design this study to evaluate the optimal regimen for induction and procedure during bronchoscopy. We hope this study could provide the more safety and efficient bronchoscopic sedation for patients and physicians.

Conditions: Flexible Bronchoscopy
Being tested: TCI titration by different Cet.
Keywords: Target-controlled infusion,, bronchoscopy,, sedation,, propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TCI titration by different Cet.Procedure or surgery
Induction:
After topical xylocaine and alfentanil 5μg/kg iv 1 minute before, Cet 2.0μg/ml is started on the TCI pump ('Vial" Injectomat TIVA Agilia syringe infusion pump, Fresenius Kabi, France). The sedative level will be accessed by sedation scale "OAA/S" every 30 seconds till OAA/S ≦3(Responds only to name called loudly). The current Ce will be set as the maintenance Cet.
If desired OAA/S is not achieved after reaching 2.0μg/ml,Cet will be increased every 90 seconds by the regimens be assigned until OAA/S ≦3. The current Ce will be set as the maintenance Cet.
Maintenance:
The Cet will be increased according to the assigned regimens if:
1. Patients become irritant and interfere procedures.
2. Patients open eyes or talk to express uncomfortable.
The Cet will be decreased if:
1. Systolic blood pressure is less than 90mmHg;
2. Mean arterial blood pressure is less than 65mmHg;
3. Oxyhemoglobin saturation is less than 90 % with any duration.

Study groups in NCT01101477
Study group	Role	What they receive
Titration by target effect site concentration (Cet) 0.5μg/ml	Active comparator	The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention. Receives: Procedure: TCI titration by different Cet.
Titration by Cet 0.2μg/ml	Active comparator	The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention. Receives: Procedure: TCI titration by different Cet.
Titration by Cet 0.1μg/ml	Active comparator	The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention. Receives: Procedure: TCI titration by different Cet.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Patients With Hypoxemia During Flexible Bronchoscopy
Hypoxemia is defined as:
Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration
Measured: During sedative induction and bronchoscopy
The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy
The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.
Measured: During sedative induction and bronchoscopy

Secondary outcomes (4)

The Recovery Time to Orientation
The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.
Measured: after bronchosocpy
The Total Doses of Propofol During Induction and Overall Procedures
The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.
Measured: after bronchoscopy
The Cooperation of Patients From the View of Bronchoscopists
After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.
Measured: After bronchoscopy
The Global Tolerance for Flexible Bronchoscopy
After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)
Measured: After recovery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Aug 2010

First posted12 Apr 2010 (estimated)
Study startFeb 2010
Primary completionAug 2010
Study completionAug 2010

Why it stopped: Hypoxemia(SPaO2\<80%) episodes occured significantly in the arm titration by 0.5ug/ml

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 (2)Papers the sponsor has linked to this study.
Other trials for Flexible BronchoscopyStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101477
Sponsor's protocol ID: 98-3441A3
Status last verified: Nov 2011
First submitted: 7 Apr 2010
Last updated: 8 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fanti L, Agostoni M, Arcidiacono PG, Albertin A, Strini G, Carrara S, Guslandi M, Torri G, Testoni PA. Target-controlled infusion during monitored anesthesia care in patients undergoing EUS: propofol alone versus midazolam plus propofol. A prospective double-blind randomised controlled trial. Dig Liver Dis. 2007 Jan;39(1):81-6. doi: 10.1016/j.dld.2006.09.004. Epub 2006 Oct 16.
PubMed 17049322
Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.
PubMed 23638141

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruiting
Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy
Recruiting
Comparison of Double-lumen Tube Intubation Between Fiberoptic Bronchoscopy and Video Laryngoscope
One Lung Ventilation in Thoracic Surgery
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
RecruitingObservational study
Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
Airway Management, Fiberoptic Guided Intubation

All Flexible Bronchoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation: Determining the Optimal Titrating Regimen
ClinicalTrials.gov ID: NCT01101477
Acronym / sponsor ID: 98-3441A3
Conditions: Flexible Bronchoscopy
Keywords: Target-controlled infusion,, bronchoscopy,, sedation,, propofol
Study type: Interventional
Recruitment status: TerminatedReason stopped: Hypoxemia(SPaO2\<80%) episodes occured significantly in the arm titration by 0.5ug/ml
Enrolment: 144 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: Feb 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 12 Apr 2010 (estimated)
Results: Posted 8 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Titration by target effect site concentration (Cet) 0.5μg/ml	Active comparator	Procedure: TCI titration by different Cet.The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
Titration by Cet 0.2μg/ml	Active comparator	Procedure: TCI titration by different Cet.The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
Titration by Cet 0.1μg/ml	Active comparator	Procedure: TCI titration by different Cet.The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients (18 years old or more) required elective flexible bronchoscopy and sedation.

Key exclusion criteria (5 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.
Mallampati score 4 or 5.
Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
Men with body mass index(BMI) large than 42，Females with BMI large than 35.
Allergic history to study drugs.

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
TCI titration by different Cet.Induction: After topical xylocaine and alfentanil 5μg/kg iv 1 minute before, Cet 2.0μg/ml is started on the TCI pump ('Vial" Injectomat TIVA Agilia syringe infusion pump, Fresenius Kabi, France). The sedative level will be accessed by sedation scale "OAA/S" every 30 seconds till OAA/S ≦3(Responds only to name called loudly). The current Ce will be set as the maintenance Cet. If desired OAA/S is not achieved after reaching 2.0μg/ml,Cet will be increased every 90 seconds by the regimens be assigned until OAA/S ≦3. The current Ce will be set as the maintenance Cet. Maintenance: The Cet will be increased according to the assigned regimens if: 1. Patients become irritant and interfere procedures. 2. Patients open eyes or talk to express uncomfortable. The Cet will be decreased if: 1. Systolic blood pressure is less than 90mmHg; 2. Mean arterial blood pressure is less than 65mmHg; 3. Oxyhemoglobin saturation is less than 90 % with any duration.	Procedure or surgery	Titration by Cet 0.1μg/ml, Titration by Cet 0.2μg/ml, Titration by target effect site concentration (Cet) 0.5μg/ml

Primary outcome

The Number of Patients With Hypoxemia During Flexible Bronchoscopy
Time frame: During sedative induction and bronchoscopy
Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration
The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy
Time frame: During sedative induction and bronchoscopy
The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.

4 secondary outcomes

The Recovery Time to Orientation
Time frame: after bronchosocpy
The Total Doses of Propofol During Induction and Overall Procedures
Time frame: after bronchoscopy
The Cooperation of Patients From the View of Bronchoscopists
Time frame: After bronchoscopy
The Global Tolerance for Flexible Bronchoscopy
Time frame: After recovery

Results and safety

Results posted to the registry on 8 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Titration by Target Effect Site Concentration (Cet) 0.5μg/ml	49	44
Titration by Cet 0.2μg/ml	49	46
Titration by Cet 0.1μg/ml	46	45

Primary outcome: The Number of Patients With Hypoxemia During Flexible Bronchoscopy

Time frame: During sedative induction and bronchoscopy. Number. Unit: participants

Measure	Titration by Target Effect Site Concentration (Cet) 0.5μg/ml n = 44	Titration by Cet 0.2μg/ml n = 46	Titration by Cet 0.1μg/ml n = 45
Value	29	22	18

Titration by Target Effect Site Concentration (Cet) 0.5μg/ml vs Titration by Cet 0.2μg/ml vs Titration by Cet 0.1μg/ml: p = 0.05, Chi-squared

Population analysed: The participants who received intervention completely were analyzed.

Primary outcome: The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy

Time frame: During sedative induction and bronchoscopy

The sponsor has not posted figures for this outcome.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the starting of induction to patients leaving the bronchoscopic room after recovery.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Titration by Target Effect Site Concentration (Cet) 0.5μg/ml	0 of 44 (0%)	6 of 44 (13.6%)	Not reported
Titration by Cet 0.2μg/ml	0 of 46 (0%)	1 of 46 (2.2%)	Not reported
Titration by Cet 0.1μg/ml	0 of 45 (0%)	2 of 45 (4.4%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17049322Fanti L, Agostoni M, Arcidiacono PG, Albertin A, Strini G, Carrara S, Guslandi M, Torri G, Testoni PA. Target-controlled infusion during monitored anesthesia care in patients undergoing EUS: propofol alone versus midazolam plus propofol. A prospective double-blind randomised controlled trial. Dig Liver Dis. 2007 Jan;39(1):81-6. doi: 10.1016/j.dld.2006.09.004. Epub 2006 Oct 16.
Derived from this study: PubMed 23638141Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.

Related trials for Flexible Bronchoscopy

Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruiting
Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy
Recruiting
Comparison of Double-lumen Tube Intubation Between Fiberoptic Bronchoscopy and Video Laryngoscope
One Lung Ventilation in Thoracic Surgery
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
RecruitingObservational study
Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
Airway Management, Fiberoptic Guided Intubation

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

Department 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 study testing TCI titration by different Cet. 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 5 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: stopped early, as of the sponsor's last update on 8 Dec 2011. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2011). 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 Patients With Hypoxemia During Flexible Bronchoscopy (time frame: During sedative induction and bronchoscopy). The study lists 2 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 NCT01101477, which also lists 2 linked publications.

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 Dec 2011.