N/A
Completed N=150
Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy
Sedation, Bronchoscopy
Source: ClinicalTrials.gov NCT03357393 ↗
Enrolled (actual)
150
Serious AEs
2.7%
Results posted
Jan 2021
Primary outcomePrimary: Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours — 19; 30; 45 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours |
19; 30; 45 | — |
| SECONDARY Assessment of Self-rated Patient Questionaries' Using S-PSR |
55; 56; 54 | — |
| SECONDARY Quality of Recovery (QoR-23) |
100; 102; 100 | — |
| SECONDARY Patients' Satisfaction Using a Likert-type Scale |
5; 5; 5 | — |
| SECONDARY Bronchoscopist Evaluation Using a Likert-type Scale |
5; 4; 4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03357393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.