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NCT Number: NCT07653867

Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies 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 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.

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Key information

Conditions

Colonoscopy (Procedure)

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 quistioneeres

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

Self administred propofol

Drug

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.

Nurse assisted propofol sedation

Drug

The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination

Primary outcomes

  1. Patient satisfaction

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

    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 with the sedation.

Secondary outcomes

  1. Total propofol dose (mg)

    Time frame: 0 hours after examination

    Total given dose during the examination

  2. Recovery time

    Time frame: 4 hours after the examination

    Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours

  3. Procedure duration

    Time frame: 0 hours after examination

    Time to completion of the procedure (min)

  4. 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, Docent

CONTACT

[email protected]

+46 8 123 71956

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: PCAPS1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 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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