Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participants maximal pain level
研究概览
简要总结
The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).
详细描述
The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation.
Participants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. This allows the patient to self-control their sedation/analgesia during SVP implantation. The pump enables the patient via a hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.
Each SVP implantation procedure is separated into four time points at which sedation scores are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed by an anaesthesiologist according to hospital protocol.
Participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.
Adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.
排除标准
- •Inability to operate the PCS apparatus,
- •Inability to communicate in Scandinavian languages.
- •Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea).
- •Propofol or alfentanil allergy.
- •Intake of food (or clear fluids) within six (or two) hours prior to the procedure.
- •Failure to achieve peripheral vascular access.
- •Pregnancy
结局指标
主要结局
Participants maximal pain level
时间窗: 10 minutes before discharge from recovery area
Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire.
次要结局
- Participants maximal pain from arm where infusion is(10 minutes before discharge from recovery area)
- Procedural time consumption(after completion of procedure)
- Delivered doses of propofol and alfentanil(after completion of procedure)
- Grading of implantation conditions by the implanting physician(after completion of procedure)
- Participants overall satisfaction(10 minutes before discharge from recovery area)
- Participants satisfaction with staff(10 minutes before discharge from recovery area)
- Participants satisfaction with pain treatment during implantation(10 minutes before discharge from recovery area)
- Participants evaluation of the importance of receiving sedatives during the procedure(10 minutes before discharge from recovery area)
- Participants evaluation of the importance of being in control of sedation administration(10 minutes before discharge from recovery area)
研究者
Stefanie Seifert
Principal Investigator
Region Jönköping County