Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-05 @ 9:22 PM
Study NCT ID:
NCT03357393
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lena.nilsson@regionostergotland.se', 'phone': '+46 10 103 00 00', 'title': 'Lena Nilsson', 'phoneExt': '1838', 'organization': 'Region Östergötland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure', 'description': 'In the incident report the following grading is used to rate the severity of an incidence:\n\n* Mild = aware of the symptoms but they are tolerable\n* Moderate = symptoms partially affect daily activities\n* Severe = symptoms significantly affect daily activities\n\nThe investigator assesses the relationship between the incidence and the study, as defined:\n\n• Likely = good reasons and sufficient documentation to suspect caus', 'eventGroups': [{'id': 'EG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 3, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 2, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizzyness, confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'bradycardia', 'notes': 'Severe short bradycardia during sedaation. Required pharmacological treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overnight admission', 'notes': 'Unplanned overnight admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours after bronchoscopy is finished', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Assessment of Self-rated Patient Questionaries' Using S-PSR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '77'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '73'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery (QoR-23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '112'}, {'value': '102', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '115'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '115'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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.', 'description': 'Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patients' Satisfaction Using a Likert-type Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bronchoscopist Evaluation Using a Likert-type Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Directly after completion of the procedure.', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.', 'description': "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:\n\nResponds 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", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Interventions Performed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'OG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Arterial Oxygen Saturation (SpO2)', 'timeFrame': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Respiratory Rate Per Minute (RR)', 'timeFrame': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Non-invasive Blood Pressure (mmHg)', 'timeFrame': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heart Rate (Beats Per Minute, HR).', 'timeFrame': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'FG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'FG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam and Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.\n\nMidazolam: Midazolam is givenas sedation to the Control arm.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'BG001', 'title': 'PCS (Propofol) With Morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nmorphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.'}, {'id': 'BG002', 'title': 'PCS (Propofol) With Glycopyrronium Bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.\n\nPropofol-Lipuro: Propofol is given as sedation to both intervention arms.\n\nGlycopyrrolate: Given as premedication for one of the intervention arms..'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '83'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '86'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '89'}, {'value': '69', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-29', 'size': 2092053, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-04T09:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2017-11-07', 'resultsFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-31', 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale", 'timeFrame': 'Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.', 'description': "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:\n\nResponds 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"}, {'measure': 'Number of Participants With Interventions Performed', 'timeFrame': 'From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.', 'description': '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.'}, {'measure': 'Arterial Oxygen Saturation (SpO2)', 'timeFrame': '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.'}, {'measure': 'Respiratory Rate Per Minute (RR)', 'timeFrame': '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.'}, {'measure': 'Non-invasive Blood Pressure (mmHg)', 'timeFrame': '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.'}, {'measure': 'Heart Rate (Beats Per Minute, HR).', 'timeFrame': '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.'}], 'primaryOutcomes': [{'measure': 'Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours', 'timeFrame': '2 hours after bronchoscopy is finished', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Assessment of Self-rated Patient Questionaries' Using S-PSR", 'timeFrame': '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.', 'description': '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': 'Quality of Recovery (QoR-23)', 'timeFrame': '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.', 'description': 'Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery.\n\nThe 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.'}, {'measure': "Patients' Satisfaction Using a Likert-type Scale", 'timeFrame': 'After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.', 'description': '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.'}, {'measure': 'Bronchoscopist Evaluation Using a Likert-type Scale', 'timeFrame': 'Directly after completion of the procedure.', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedation, Bronchoscopy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* Planned bronchoscopic procedure with sedation in an outpatient setting\n* The patient have after receiving information about the study given his/her signed informed consent to participate.\n* Women of childbearing potential only if use of effective contraceptive.\n\nExclusion Criteria:\n\n* Positive pregnancy test S-β-HCG.\n* Known/suspected allergy or contraindication\\* to any medication within the study.\n* Functional disability in both hands which affect the possibility to operate the PCS device.\n* Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.'}, 'identificationModule': {'nctId': 'NCT03357393', 'briefTitle': 'Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BRONSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam and morphine-scopolamine', 'description': 'Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.', 'interventionNames': ['Drug: Midazolam', 'Drug: morphine-scopolamine']}, {'type': 'EXPERIMENTAL', 'label': 'PCS (propofol) with morphine-scopolamine', 'description': 'Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication', 'interventionNames': ['Drug: Propofol-Lipuro', 'Drug: morphine-scopolamine']}, {'type': 'EXPERIMENTAL', 'label': 'PCS (propofol) with glycopyrronium bromide', 'description': 'Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.', 'interventionNames': ['Drug: Propofol-Lipuro', 'Drug: Glycopyrrolate']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam is givenas sedation to the Control arm.', 'armGroupLabels': ['Midazolam and morphine-scopolamine']}, {'name': 'Propofol-Lipuro', 'type': 'DRUG', 'description': 'Propofol is given as sedation to both intervention arms.', 'armGroupLabels': ['PCS (propofol) with glycopyrronium bromide', 'PCS (propofol) with morphine-scopolamine']}, {'name': 'morphine-scopolamine', 'type': 'DRUG', 'description': 'Given as premedication for the Control arm and one of the interventions arms.', 'armGroupLabels': ['Midazolam and morphine-scopolamine', 'PCS (propofol) with morphine-scopolamine']}, {'name': 'Glycopyrrolate', 'type': 'DRUG', 'description': 'Given as premedication for one of the intervention arms..', 'armGroupLabels': ['PCS (propofol) with glycopyrronium bromide']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lena Nilsson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lena Nilsson', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}