Clinical trial NCT03357393: Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy
Official title: Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation, Bronchoscopy
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
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.
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.
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.
measure: Bronchoscopist Evaluation Using a Likert-type Scale
timeFrame: Directly after completion of the procedure.
Other outcomes:
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.
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.
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.
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