Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction

NCT07653867 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: PCAPS12025-524859-31-00
• Study Type: interventional
• Target: 135
• 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 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.

Conditions

Colonoscopy (Procedure)

Keywords

colonoscopy; sedation; patient controlled propofol sedation

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 with the sedation.

  One hour after the examination and one week after the examination

Secondary Outcomes (4)

• Total propofol dose (mg)

  0 hours after examination

• Recovery time

  4 hours after the examination

• Procedure duration

  0 hours after examination

• Adverse events

  30 days

Study Arms (2)

Patient controlled propofol sedation

EXPERIMENTAL

Patients will self administer propofol by pushing a button (5 mg iv, 8 activations per minute resulting in max dose of 40 mg propofol/minute) as needed

Drug: Self administred propofol

Nurse assisted propofol sedation

ACTIVE COMPARATOR

The endoscopy nurse will administer propofol in bolus doses of 10 mg iv as needed

Drug: Nurse assisted propofol sedation

Interventions

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.

Patient controlled propofol sedation

Nurse assisted propofol sedation DRUG

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

Nurse assisted propofol sedation

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 quistioneeres

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

Study Sites (2)

Endoscopy Unit, StGörans Hospital

Stockholm, Sweden

Location

Endoskopicentrum, Danderyds Hospital

Stockholm, Sweden

Location

Study Officials

• Richard E Marsk, Docent

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard E Marsk, 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 17, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 17, 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)