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

NCT07637279 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: PCAPS22025-524859-31-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Colo-rectal Polyps

Keywords

Colonoscopy; Endoscopic submucosal dissection; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Recovery time

  <4 hours post examination

• Procedure duration

  Postprocedure

• Adverse events

  30 days

Study Arms (2)

Patient controlled propofol sedation

EXPERIMENTAL

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

Standard conscious sedation with midazolam and fentanyl

ACTIVE COMPARATOR

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

Interventions

Patient controlled analgesia DRUG

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

Patient controlled propofol sedation

Standard medical treatment DRUG

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

Standard conscious sedation with midazolam and fentanyl

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Danderyd Hospital: collaborator
• Capio Sankt Görans Hospital: collaborator

Study Sites (2)

Endoscopy Unit, StGörans Hospital

Stockholm, Sweden

Location

Endoskopicentrum, Danderyds Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Richard E Marsk, MD, Docent

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard E Marsk, MD, Docent

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• 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.

Locations

SE (2)