Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Midazolam and morphine-scopolamine
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
干预措施: Midazolam (Drug)
Midazolam and morphine-scopolamine
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
干预措施: morphine-scopolamine (Drug)
PCS (propofol) with morphine-scopolamine
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
干预措施: Propofol-Lipuro (Drug)
PCS (propofol) with morphine-scopolamine
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
干预措施: morphine-scopolamine (Drug)
PCS (propofol) with glycopyrronium bromide
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
干预措施: Propofol-Lipuro (Drug)
PCS (propofol) with glycopyrronium bromide
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
时间窗: 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.
次要结局
- 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.)
- 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.)
- Bronchoscopist Evaluation Using a Likert-type Scale(Directly after completion of the procedure.)
研究者
Lena Nilsson
Principal Investigator
University Hospital, Linkoeping