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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524859-31-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Nurse assisted propofol sedation | Active Comparator | The endoscopy nurse will administer propofol in bolus doses of 10 mg iv as needed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total propofol dose (mg) | Total given dose during the examination | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard E Marsk, Docent | Contact | +46 8 123 71956 | richard.marsk@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Richard E Marsk, Docent | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit, StGörans Hospital | Stockholm | Sweden |
De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared data will include all variables necessary to reproduce the findings presented in the article.
Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.
Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.
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| Nurse assisted propofol sedation | Drug | The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination |
|
| 4 hours after the examination |
| Procedure duration | Time to completion of the procedure (min) | 0 hours after examination |
| Adverse events | Any adverse events related to sedation within 30 days | 30 days |
| Endoskopicentrum, Danderyds Hospital | Stockholm | Sweden |
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