Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Self administred propofol
  Patients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.
• Препарат Nurse assisted propofol sedation
  The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination

Первичные конечные точки

• Patient satisfaction [Срок оценки: One hour after the examination and one week after the examination]

Вторичные конечные точки (4)

• Total propofol dose (mg) [Срок оценки: 0 hours after examination]
• Recovery time [Срок оценки: 4 hours after the examination]
• Procedure duration [Срок оценки: 0 hours after examination]
• Adverse events [Срок оценки: 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Швеция · 2 центра

• Endoscopy Unit, StGörans Hospital — Stockholm
• Endoskopicentrum, Danderyds Hospital — Stockholm

Идентификаторы

NCT: NCT07653867 · PCAPS1 · 2025-524859-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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