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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07637279

Acronym

PCAPS2

Enrollment

Registered

2026-06-09

Start date

2026-11-01

Completion date

2028-11-01

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Polyps

Keywords

Colonoscopy, Endoscopic submucosal dissection, Patient satisfaction

Brief summary

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.

Interventions

DRUGPatient controlled analgesia

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

DRUGStandard medical treatment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Patient satisfaction	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

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

Countries

Sweden

Contacts

CONTACTRichard E Marsk, MD, Docent

richard.marsk@ki.se+46 8 123 71956

PRINCIPAL_INVESTIGATORRichard E Marsk, MD, Docent

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026