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

Phase 4Not Yet RecruitingNCT07653867

Karolinska Institutet135 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

135

Conditions

Colonoscopy (Procedure)

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 quistioneeres 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.

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 with the sedation.

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

Secondary Outcomes

Total propofol dose (mg)

Total given dose during the examination

Time frame: 0 hours after examination

Recovery time

Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours

Time frame: 4 hours after the examination

Procedure duration

Time to completion of the procedure (min)

Time frame: 0 hours after examination

Adverse events

Any adverse events related to sedation within 30 days

Time frame: 30 days