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临床试验/NCT07653867
NCT07653867尚未招募4 期

Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Diagnostic Colonoscopies

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2026年11月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
135
试验地点
2

研究概览

简要总结

The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies.

• Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary)

Participants will:

  • Be randomized to either sedation route.
  • Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective diagnostic colonoscopy in propofol sedation
  • Able to understand the study information and provide inform consent
  • Able to understand and use the patient-controlled sedation device
  • Able to complete study quistioneeres

排除标准

  • ASA >=III
  • Known hypersensitivity or contraindication to propofol or any excipient in the formulation.
  • Pregnancy or breastfeeding.
  • Inability to provide valid informed consent
  • Cognitive impairment, severe psychiatric illness, or other condition limiting reliable participation or questionnaire completion.
  • Inability to understand study procedures or insufficient language proficiency without available validated study support.
  • History of serious adverse reaction or complication related to sedation or anesthesia.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Marsk

Associate professor

Karolinska Institutet

研究点 (2)

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