Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam and morphine-scopolamine | Active Comparator | Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. |
|
| PCS (propofol) with morphine-scopolamine | Experimental | Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication |
|
| PCS (propofol) with glycopyrronium bromide | Experimental | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Midazolam is givenas sedation to the Control arm. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours after bronchoscopy is finished |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | Level of sedation is assessed every 5th minute during the procedure by the nurse anaesthetist using The Observer's Assessment of Alertness/Sedation (OAA/S) scale whereby a higher score represent a lighter sedation. Below is the scale descriped, Observation/score: Responds readily to name spoken in normal tone/5 Lethargic response to name spoken in normal tone/4 Responds only after name is called loudly and/or repeatedly/3 Responds only after mild prodding or shaking/2 Does not respond to mild prodding or shaking/1 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam and Morphine-scopolamine | Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. Midazolam: Midazolam is givenas sedation to the Control arm. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| FG001 | PCS (Propofol) With Morphine-scopolamine | Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication Propofol-Lipuro: Propofol is given as sedation to both intervention arms. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| FG002 | PCS (Propofol) With Glycopyrronium Bromide | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. Propofol-Lipuro: Propofol is given as sedation to both intervention arms. Glycopyrrolate: Given as premedication for one of the intervention arms.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam and Morphine-scopolamine | Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. Midazolam: Midazolam is givenas sedation to the Control arm. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 2 hours after bronchoscopy is finished |
|
From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence:
The investigator assesses the relationship between the incidence and the study, as defined:
• Likely = good reasons and sufficient documentation to suspect caus
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam and Morphine-scopolamine | Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication. Midazolam: Midazolam is givenas sedation to the Control arm. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Systematic Assessment | Severe short bradycardia during sedaation. Required pharmacological treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizzyness, confusion | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lena Nilsson | Region Östergötland | +46 10 103 00 00 | 1838 | lena.nilsson@regionostergotland.se |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 29, 2016 | Dec 4, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D015742 | Propofol |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).
| Propofol-Lipuro |
| Drug |
Propofol is given as sedation to both intervention arms. |
|
| morphine-scopolamine | Drug | Given as premedication for the Control arm and one of the interventions arms. |
|
| Glycopyrrolate | Drug | Given as premedication for one of the intervention arms.. |
|
| 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. | 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. | 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). | Directly after completion of the procedure. |
| Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. |
| Number of Participants With Interventions Performed | Number of participants with interventions performed to maintain cardiovascular (if atropine or ephidrine has been given) and respiratory stability (if assisted ventilation, chin lift or painful stimulation has been performed). Assesed every five minutes during the procedure. | From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. |
| Arterial Oxygen Saturation (SpO2) | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. |
| Respiratory Rate Per Minute (RR) | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. |
| Non-invasive Blood Pressure (mmHg) | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. |
| Heart Rate (Beats Per Minute, HR). | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. |
| PCS (Propofol) With Morphine-scopolamine |
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication Propofol-Lipuro: Propofol is given as sedation to both intervention arms. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| BG002 | PCS (Propofol) With Glycopyrronium Bromide | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. Propofol-Lipuro: Propofol is given as sedation to both intervention arms. Glycopyrrolate: Given as premedication for one of the intervention arms.. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PCS (Propofol) With Morphine-scopolamine | Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication Propofol-Lipuro: Propofol is given as sedation to both intervention arms. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. |
| OG002 | PCS (Propofol) With Glycopyrronium Bromide | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. Propofol-Lipuro: Propofol is given as sedation to both intervention arms. Glycopyrrolate: Given as premedication for one of the intervention arms.. |
|
|
| Secondary | 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. | Posted | Median | Full Range | units on a scale | 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. |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | score on a scale | 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. |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | units on a scale | After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours. |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | units on a scale | Directly after completion of the procedure. |
|
|
|
| Other Pre-specified | Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | Level of sedation is assessed every 5th minute during the procedure by the nurse anaesthetist using The Observer's Assessment of Alertness/Sedation (OAA/S) scale whereby a higher score represent a lighter sedation. Below is the scale descriped, Observation/score: Responds readily to name spoken in normal tone/5 Lethargic response to name spoken in normal tone/4 Responds only after name is called loudly and/or repeatedly/3 Responds only after mild prodding or shaking/2 Does not respond to mild prodding or shaking/1 | Posted | Median | Full Range | units on a scale | Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. |
|
|
|
| Other Pre-specified | Number of Participants With Interventions Performed | Number of participants with interventions performed to maintain cardiovascular (if atropine or ephidrine has been given) and respiratory stability (if assisted ventilation, chin lift or painful stimulation has been performed). Assesed every five minutes during the procedure. | Posted | Count of Participants | Participants | From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. |
|
|
|
| Other Pre-specified | Arterial Oxygen Saturation (SpO2) | Not Posted | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. | Participants |
| Other Pre-specified | Respiratory Rate Per Minute (RR) | Not Posted | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. | Participants |
| Other Pre-specified | Non-invasive Blood Pressure (mmHg) | Not Posted | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. | Participants |
| Other Pre-specified | Heart Rate (Beats Per Minute, HR). | Not Posted | Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours. | Participants |
| 0 |
| 50 |
| 3 |
| 50 |
| 3 |
| 50 |
| EG001 | PCS (Propofol) With Morphine-scopolamine | Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication Propofol-Lipuro: Propofol is given as sedation to both intervention arms. morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms. | 0 | 50 | 0 | 50 | 6 | 50 |
| EG002 | PCS (Propofol) With Glycopyrronium Bromide | Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication. Propofol-Lipuro: Propofol is given as sedation to both intervention arms. Glycopyrrolate: Given as premedication for one of the intervention arms.. | 0 | 50 | 1 | 50 | 2 | 50 |
|
| Overnight admission | General disorders | Systematic Assessment | Unplanned overnight admission |
|
| Fever | General disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Male |
|