Sedation, BronchoscopyNCT03357393
Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy
A study testing Midazolam, Propofol-Lipuro and morphine-scopolamine in people with Sedation, Bronchoscopy, run by Lena Nilsson.
Trial summary
bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with parallel groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedation, Bronchoscopy
- What is being tested?
- Midazolam, Propofol-Lipuro and morphine-scopolamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2016to 9 May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years)
- Planned bronchoscopic procedure with sedation in an outpatient setting
- The patient have after receiving information about the study given his/her signed informed consent to participate.
- Women of childbearing potential only if use of effective contraceptive.
Who cannot join
- Positive pregnancy test S-β-HCG.
- Known/suspected allergy or contraindication* to any medication within the study.
- Functional disability in both hands which affect the possibility to operate the PCS device.
- Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.
About this study
Official title: Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial
bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS and morphine-scopolamine as premedication, and sedation with propofol using PCS and glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms). The hypothesis is that PCS increase the amount of patients ready for discharge, and further that patient characteristics affect the amount of propofol administered. The endpoints are primarily the amount of patients ready for discharge within 2 hours and secondary assessment of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of administrated drugs. Finally safety variables are collected such as vital signs and interventions performed to maintain cardiovascular and respiratory stability.
- Conditions
- Sedation, Bronchoscopy
- Being tested
- Midazolam, Propofol-Lipuro, morphine-scopolamine, Glycopyrrolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam is givenas sedation to the Control arm.
Propofol-LipuroDrug
Propofol is given as sedation to both intervention arms.
morphine-scopolamineDrug
Given as premedication for the Control arm and one of the interventions arms.
GlycopyrrolateDrug
Given as premedication for one of the intervention arms..
| Study group | Role | What they receive |
|---|---|---|
| Midazolam and morphine-scopolamine | Active comparator | Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. Receives: Drug: Midazolam; Drug: morphine-scopolamine |
| PCS (propofol) with morphine-scopolamine | Experimental | Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication Receives: Drug: Propofol-Lipuro; Drug: morphine-scopolamine |
| PCS (propofol) with glycopyrronium bromide | Experimental | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. Receives: Drug: Propofol-Lipuro; Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
Post Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours.
Measured: 2 hours after bronchoscopy is finished
Secondary outcomes (4)
Assessment of Self-rated Patient Questionaries' Using S-PSR
Post-discharge Surgical Recovery Scale (S-PSR) The modified Swedish version S-PSR is based on the "Post-discharge Surgical Recovery Scale" and is a 14-item questionnaire to assess the recovery post-discharge regarding the patients' health status and activity (see further appendix 2). Each item is rated using a semantic differential scale and the total sum is multiplied by 100. The possible range is 10-100, with higher score indicating a more favourable postoperative recovery.
Measured: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the evening on the day of bronchoscopy. It takes approximately 2 minutes to complete the questionnaire.
Quality of Recovery (QoR-23)
Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery.
The questionnaire "Quality of Recovery" (QoR-23) is a 23 item questionnaire to assess recovery after day surgery regarding the patients' emotional state, physical comfort and physical independence (see further appendix 4). Each item is rated on a five-point scale (1-5) and the scores are summed.
Measured: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the morning the day after bronchoscopy. It takes less than 1 minute to complete the assessment.
Patients' Satisfaction Using a Likert-type Scale
overall satisfaction with the procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied). The patient may comment any cause which made the satisfaction score high or low and if the patient would like to receive the same method of sedation during a future bronchoscopy.
Measured: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.
Bronchoscopist Evaluation Using a Likert-type Scale
the bronchoscopist assess their perception of cough, bronchial secretion respectively circumstances for a smooth performance of the bronchoscopy of procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied).
Measured: Directly after completion of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start4 Apr 2016
- Primary completion9 May 2017
- Study completion9 May 2017
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.
- Other trials for Sedation, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lena Nilsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lena Nilsson, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357393
- Sponsor's protocol ID
- BRONSE
- Status last verified
- Dec 2020
- First submitted
- 7 Nov 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03357393
- Acronym / sponsor ID
- BRONSE
- Conditions
- Sedation, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lena NilssonUniversity, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS and morphine-scopolamine as premedication, and sedation with propofol using PCS and glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms). The hypothesis is that PCS increase the amount of patients ready for discharge, and further that patient characteristics affect the amount of propofol administered. The endpoints are primarily the amount of patients ready for discharge within 2 hours and secondary assessment of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of administrated drugs. Finally safety variables are collected such as vital signs and interventions performed to maintain cardiovascular and respiratory stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam and morphine-scopolamine | Active comparator | Drug: Midazolam, Drug: morphine-scopolamineSedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. |
| PCS (propofol) with morphine-scopolamine | Experimental | Drug: Propofol-Lipuro, Drug: morphine-scopolamineSedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication |
| PCS (propofol) with glycopyrronium bromide | Experimental | Drug: Propofol-Lipuro, Drug: GlycopyrrolateSedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥18 years)
- Planned bronchoscopic procedure with sedation in an outpatient setting
- The patient have after receiving information about the study given his/her signed informed consent to participate.
- Women of childbearing potential only if use of effective contraceptive.
Key exclusion criteria (4 listed)
- Positive pregnancy test S-β-HCG.
- Known/suspected allergy or contraindication* to any medication within the study.
- Functional disability in both hands which affect the possibility to operate the PCS device.
- Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.
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 |
|---|---|---|
| MidazolamMidazolam is givenas sedation to the Control arm. | Drug | Midazolam and morphine-scopolamine |
| Propofol-LipuroPropofol is given as sedation to both intervention arms. | Drug | PCS (propofol) with glycopyrronium bromide, PCS (propofol) with morphine-scopolamine |
| morphine-scopolamineGiven as premedication for the Control arm and one of the interventions arms. | Drug | Midazolam and morphine-scopolamine, PCS (propofol) with morphine-scopolamine |
| GlycopyrrolateGiven as premedication for one of the intervention arms.. | Drug | PCS (propofol) with glycopyrronium bromide |
Primary outcome
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
Time frame: 2 hours after bronchoscopy is finished
Post Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours.
4 secondary outcomes
Assessment of Self-rated Patient Questionaries' Using S-PSR
Time frame: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the evening on the day of bronchoscopy. It takes approximately 2 minutes to complete the questionnaire.
Quality of Recovery (QoR-23)
Time frame: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the morning the day after bronchoscopy. It takes less than 1 minute to complete the assessment.
Patients' Satisfaction Using a Likert-type Scale
Time frame: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.
Bronchoscopist Evaluation Using a Likert-type Scale
Time frame: Directly after completion of the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Propofol-Lipuro and morphine-scopolamine in people with Sedation, Bronchoscopy, run by Lena Nilsson.
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 4 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 5 Jan 2021). 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?
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours (time frame: 2 hours after bronchoscopy is finished). 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 5 Jan 2021.