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NCT Number: NCT07637279

Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction

The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to standard conscious sedation in advanced therapeutic endoscopy.

• 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 standard conscious sedation

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.

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Key information

Conditions

Colo-rectal Polyps Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endoscopy Unit, StGörans Hospital, Stockholm, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 questioneeres

Exclusion criteria

  • 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.

Treatment and study plan

patient controlled analgesia

Drug

Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute

Standard Medical Treatment

Drug

Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse

Primary outcomes

  1. Patient satisfaction

    Time frame: One hour after the procedure and one week after the procedure

    Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions. Each question with 5 ranks (1-5). Minimum score 13, maximum score 65. Higher score indicates higher satisfaction.

Secondary outcomes

  1. Recovery time

    Time frame: <4 hours post examination

    Time before the patient can be discharged from the endoscopy unit.

  2. Procedure duration

    Time frame: Postprocedure

    Time to completion of the procedure (min)

  3. Adverse events

    Time frame: 30 days

    Any adverse events related to sedation within 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Richard E Marsk, MD, Docent

CONTACT

[email protected]

+46 8 123 71956

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Capio Sankt Görans Hospital
  • Danderyd Hospital

Registry information

Official study title

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

Acronym: PCAPS2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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