Sedation, Bronchoscopy
Conditions
Brief 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. 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.
Interventions
DRUGMidazolam
Midazolam is givenas sedation to the Control arm.
DRUGPropofol-Lipuro
Propofol is given as sedation to both intervention arms.
DRUGmorphine-scopolamine
Given as premedication for the Control arm and one of the interventions arms.
DRUGGlycopyrrolate
Given as premedication for one of the intervention arms..
Sponsors
Lena Nilsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Self-rated Patient Questionaries' Using S-PSR | 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. | 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. |
| Quality of Recovery (QoR-23) | 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. | 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. |
| Patients' Satisfaction Using a Likert-type Scale | After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours. | 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. |
| Bronchoscopist Evaluation Using a Likert-type Scale | Directly after completion of the procedure. | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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. | — |
| Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. | 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 |
| Number of Participants With Interventions Performed | From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. | 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. |
| 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. | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| 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.. | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | PCS (Propofol) With Morphine-scopolamine | PCS (Propofol) With Glycopyrronium Bromide | Total | Midazolam and Morphine-scopolamine |
|---|---|---|---|---|
| Age, Continuous | 69 years | 68 years | 69 years | 70 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Sweden | 50 participants | 50 participants | 150 participants | 50 participants |
| Sex: Female, Male Female | 22 Participants | 28 Participants | 72 Participants | 22 Participants |
| Sex: Female, Male Male | 28 Participants | 22 Participants | 78 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 3 / 50 | 6 / 50 | 2 / 50 |
| serious Total, serious adverse events | 3 / 50 | 0 / 50 | 1 / 50 |
Outcome results
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.
Time frame: 2 hours after bronchoscopy is finished
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours | 19 Participants |
| PCS (Propofol) With Morphine-scopolamine | Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours | 30 Participants |
| PCS (Propofol) With Glycopyrronium Bromide | Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours | 45 Participants |
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.
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Assessment of Self-rated Patient Questionaries' Using S-PSR | 55 units on a scale |
| PCS (Propofol) With Morphine-scopolamine | Assessment of Self-rated Patient Questionaries' Using S-PSR | 56 units on a scale |
| PCS (Propofol) With Glycopyrronium Bromide | Assessment of Self-rated Patient Questionaries' Using S-PSR | 54 units on a scale |
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).
Time frame: Directly after completion of the procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Bronchoscopist Evaluation Using a Likert-type Scale | 5 units on a scale |
| PCS (Propofol) With Morphine-scopolamine | Bronchoscopist Evaluation Using a Likert-type Scale | 4 units on a scale |
| PCS (Propofol) With Glycopyrronium Bromide | Bronchoscopist Evaluation Using a Likert-type Scale | 4 units on a scale |
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.
Time frame: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Patients' Satisfaction Using a Likert-type Scale | 5 units on a scale |
| PCS (Propofol) With Morphine-scopolamine | Patients' Satisfaction Using a Likert-type Scale | 5 units on a scale |
| PCS (Propofol) With Glycopyrronium Bromide | Patients' Satisfaction Using a Likert-type Scale | 5 units on a scale |
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.
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Quality of Recovery (QoR-23) | 100 score on a scale |
| PCS (Propofol) With Morphine-scopolamine | Quality of Recovery (QoR-23) | 102 score on a scale |
| PCS (Propofol) With Glycopyrronium Bromide | Quality of Recovery (QoR-23) | 100 score on a scale |
Other Pre-specified
Arterial Oxygen Saturation (SpO2)
Time frame: 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.
Other Pre-specified
Heart Rate (Beats Per Minute, HR).
Time frame: 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.
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
Time frame: Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | 3 units on a scale |
| PCS (Propofol) With Morphine-scopolamine | Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | 2 units on a scale |
| PCS (Propofol) With Glycopyrronium Bromide | Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale | 2 units on a scale |
Other Pre-specified
Non-invasive Blood Pressure (mmHg)
Time frame: 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.
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.
Time frame: From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Morphine-scopolamine | Number of Participants With Interventions Performed | 1 Participants |
| PCS (Propofol) With Morphine-scopolamine | Number of Participants With Interventions Performed | 4 Participants |
| PCS (Propofol) With Glycopyrronium Bromide | Number of Participants With Interventions Performed | 3 Participants |
Other Pre-specified
Respiratory Rate Per Minute (RR)
Time frame: 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.