Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

NCT03357393 | Completed Results

• 1 other identifier: BRONSE
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sedation, Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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.

• 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.

• Patients' Satisfaction Using a Likert-type Scale

  After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.

• Bronchoscopist Evaluation Using a Likert-type Scale

  Directly after completion of the procedure.

Other Outcomes (6)

• 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.

• Number of Participants With Interventions Performed

  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.

Study Arms (3)

Midazolam and morphine-scopolamine

ACTIVE COMPARATOR

Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.

Drug: Midazolam; Drug: morphine-scopolamine

PCS (propofol) with morphine-scopolamine

EXPERIMENTAL

Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication

Drug: Propofol-Lipuro; Drug: morphine-scopolamine

PCS (propofol) with glycopyrronium bromide

EXPERIMENTAL

Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.

Drug: Propofol-Lipuro; Drug: Glycopyrrolate

Interventions

Midazolam DRUG

Midazolam is givenas sedation to the Control arm.

Midazolam and morphine-scopolamine

Propofol-Lipuro DRUG

Propofol is given as sedation to both intervention arms.

PCS (propofol) with glycopyrronium bromide; PCS (propofol) with morphine-scopolamine

morphine-scopolamine DRUG

Given as premedication for the Control arm and one of the interventions arms.

Midazolam and morphine-scopolamine; PCS (propofol) with morphine-scopolamine

Glycopyrrolate DRUG

Given as premedication for one of the intervention arms..

PCS (propofol) with glycopyrronium bromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lena Nilsson: lead

MeSH Terms

Interventions

Midazolam; Propofol; Glycopyrrolate

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Lena Nilsson
• Organization: Region Östergötland

lena.nilsson@regionostergotland.se

+46 10 103 00 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 29, 2017
• Study Start: April 4, 2016
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share