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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524859-31-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
| Capio Sankt Görans Hospital | OTHER |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient controlled analgesia | Drug | Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute |
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| 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. | One hour after the procedure and one week after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | Time before the patient can be discharged from the endoscopy unit. | <4 hours post examination |
| Procedure duration | Time to completion of the procedure (min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard E Marsk, MD, Docent | Contact | +46 8 123 71956 | richard.marsk@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Richard E Marsk, MD, 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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| Standard medical treatment | Drug | Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse |
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| Postprocedure |
| Adverse events | Any adverse events related to sedation within 30 days | 30 days |
| Endoskopicentrum, Danderyds Hospital | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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