Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction (PCAPS2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colo-rectal Polyps
• Intervention / Treatment: Drug: Patient controlled analgesia; Drug: Standard medical treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Richard E Marsk, MD, Docent; Phone Number: +46 8 123 71956; Email: richard.marsk@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Endoscopy Unit, StGörans Hospital
    • Contact: Tamaki Ichiya, MD, PhD Student; Phone Number: +46 8 587 010 00; Email: tamaki.ichiya@ki.se
  • Stockholm, Sweden
    • Endoskopicentrum, Danderyds Hospital
    • Contact: Ylva Falkén, MD, PhD; Phone Number: +46 123 550 00; Email: ylva.falken@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient controlled propofol sedation; Patient controlled propofol sedation. By pushing a button the patient will be administred a bolusdose of propofol 5 mg intravenously. There is a lock-out function of max 8 administrations per minute, ie the maximum propofol dose per minute is 40 mg.	Drug: Patient controlled analgesia; Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute
Active Comparator: Standard conscious sedation with midazolam and fentanyl; Conscious sedation with midazolam and/or fentanyl administred by the endoscopy nurse. Midazolam will be given in doses of 1-2 mg intravenously. Fentanyl will be given, if needed, in doses of 0.25-0.5 mg intravenously	Drug: Standard medical treatment; Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	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.	One hour after the procedure and one week after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Time before the patient can be discharged from the endoscopy unit.	<4 hours post examination
Procedure duration	Time to completion of the procedure (min)	Postprocedure
Adverse events	Any adverse events related to sedation within 30 days	30 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Danderyd Hospital; Capio Sankt Görans Hospital
• Investigators: Principal Investigator: Richard E Marsk, MD, Docent, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Endoscopic submucosal dissection; Colonoscopy
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Anesthesia and Analgesia; Analgesia; Analgesia, Patient-Controlled
• Other Study ID Numbers: PCAPS2; 2025-524859-31-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared data will include all variables necessary to reproduce the findings presented in the article.

Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.

• IPD Sharing Time Frame: Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No