Flexible BronchoscopyPhase 4NCT02226328
Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
A Phase 4 study testing Propofol sedation and Midazolam and Fentanyl sedation in people with Flexible Bronchoscopy and Sedation, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexible Bronchoscopy, Sedation, Satisfaction
- What is being tested?
- Propofol sedation and Midazolam and Fentanyl sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Elective flexible bronchoscopy.
- Willing to be randomised
- Provide written informed consent
Who cannot join
- Allergy to contents administered
- pregnant or nursing
- <18 years of age
- Not able to complete questionnaire
- Acute condition
- severe COPD
Show all 11Show fewer
- > ASA II
- Sleep apnea
- Risk of aspiration
- Previously difficulty with anesthesia
- Difficult airway
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Hellerup, 2900
Paul F Clementsen, Professor, 0045 39 77 39 77, paul.clementsen@regionh.dk
Paul Clementsen, MD
About this study
Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.
Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.
Propofol sedation is as safe as midazolam and fentanyl sedation.
- Conditions
- Flexible Bronchoscopy, Sedation, Satisfaction, Safety
- Being tested
- Propofol sedation, Midazolam and Fentanyl sedation
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol sedationDrug
Also called ATC code: N01AX10, CAS no: 2078-54-8
Midazolam and Fentanyl sedationDrug
Also called Midazolam:, ATC code: N05CD08, CAS no: 59467-70-8, Fentanyl:
| Study group | Role | What they receive |
|---|---|---|
| Propofol sedation | Experimental | Refract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist.
Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation.
Maintenance with 10-20 mg of propofol in case of discomfort. Receives: Drug: Propofol sedation |
| Midazolam and Fentanyl sedation | Active comparator | 1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation.
Maintenance with 1 mg Midazolam in case of discomfort. Receives: Drug: Midazolam and Fentanyl sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with sedation
The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.
Measured: At discharge, on average 30 minutes after procedure termination.
Secondary outcomes (1)
Number of adverse events as a surrogate marker of safety.
Adverse events as a dichotomous value of "no event" or "event". Events are: The use of rescue medicine, and cardiopulmonary support per-operatively, blood pressure deviation from baseline over 30% of Mean Arterial Pressure, oxygen saturation < 90%, and arrhythmias will be recorded for the duration of the procedure.
Measured: During procedure. On average 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul F Clementsen, Professor, Principal investigator, University of Copenhagen at Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226328
- Sponsor's protocol ID
- 2013-004358-12
- Status last verified
- Jun 2015
- First submitted
- 19 Aug 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
- ClinicalTrials.gov ID
- NCT02226328
- Acronym / sponsor ID
- 2013-004358-12
- Conditions
- Flexible Bronchoscopy, Sedation, Satisfaction, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.
Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.
Propofol sedation is as safe as midazolam and fentanyl sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol sedation | Experimental | Drug: Propofol sedationRefract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist. Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation. Maintenance with 10-20 mg of propofol in case of discomfort. |
| Midazolam and Fentanyl sedation | Active comparator | Drug: Midazolam and Fentanyl sedation1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation. Maintenance with 1 mg Midazolam in case of discomfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective flexible bronchoscopy.
- Willing to be randomised
- Provide written informed consent
Key exclusion criteria (11 listed)
- Allergy to contents administered
- pregnant or nursing
- <18 years of age
- Not able to complete questionnaire
- Acute condition
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 |
|---|---|---|
| Propofol sedationAlso: ATC code: N01AX10, CAS no: 2078-54-8 | Drug | Propofol sedation |
| Midazolam and Fentanyl sedationAlso: Midazolam:, ATC code: N05CD08, CAS no: 59467-70-8, Fentanyl: | Drug | Midazolam and Fentanyl sedation |
Primary outcome
Satisfaction with sedation
Time frame: At discharge, on average 30 minutes after procedure termination.
The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.
1 secondary outcome
Number of adverse events as a surrogate marker of safety.
Time frame: During procedure. On average 20 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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.
Paul F Clementsen, Professor principal investigator
University of Copenhagen at Gentofte 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 Propofol sedation and Midazolam and Fentanyl sedation in people with Flexible Bronchoscopy and Sedation, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Jun 2015. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeppe Thue Jensen, MD (004526136032, jeppe.thue.jensen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with sedation (time frame: At discharge, on average 30 minutes after procedure termination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.