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

Phase 4Not Yet RecruitingNCT07637279

Karolinska Institutet40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Colo-rectal Polyps

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (2)

Endoscopy Unit, StGörans Hospital

Stockholm, Sweden

Endoskopicentrum, Danderyds Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Recovery time

Time before the patient can be discharged from the endoscopy unit.

Time frame: <4 hours post examination

Procedure duration

Time to completion of the procedure (min)

Time frame: Postprocedure

Adverse events

Any adverse events related to sedation within 30 days

Time frame: 30 days