Colo-rectal PolypsPhase 4PCAPS2NCT07637279
Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction
A Phase 4 study testing Standard medical treatment in people with Colo-rectal Polyps, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colo-rectal Polyps
- What is being tested?
- Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Endoscopy Unit, StGörans Hospital
Stockholm
Tamaki Ichiya, MD, PhD Student, +46 8 587 010 00, tamaki.ichiya@ki.se
Endoskopicentrum, Danderyds Hospital
Stockholm
Ylva Falkén, MD, PhD, +46 123 550 00, ylva.falken@regionstockholm.se
About this study
Official title: Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Therapeutic Colonoscopies
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.
- Conditions
- Colo-rectal Polyps
- Being tested
- Patient controlled analgesia, Standard medical treatment
- Keywords
- Colonoscopy, Endoscopic submucosal dissection, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient controlled analgesiaDrug
Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute
Standard medical treatmentDrug
Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Patient controlled analgesia |
| 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 Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour after the procedure and one week after the procedure
Secondary outcomes (3)
Recovery time
Time before the patient can be discharged from the endoscopy unit.
Measured: <4 hours post examination
Procedure duration
Time to completion of the procedure (min)
Measured: Postprocedure
Adverse events
Any adverse events related to sedation within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal PolypsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, St Goran's Hospital
- Responsible party
- Principal investigator, Richard Marsk, Karolinska Institutet
- Investigators
- Richard E Marsk, MD, Docent, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637279
- Sponsor's protocol ID
- PCAPS2
- Other IDs
- 2025-524859-31-00, 2025
- Acronym
- PCAPS2
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Therapeutic Colonoscopies
- ClinicalTrials.gov ID
- NCT07637279
- Acronym / sponsor ID
- PCAPS2 / PCAPS2
- Conditions
- Colo-rectal Polyps
- Keywords
- Colonoscopy, Endoscopic submucosal dissection, Patient satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital, St Goran's Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient controlled propofol sedation | Experimental | Drug: Patient controlled analgesiaPatient 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. |
| Standard conscious sedation with midazolam and fentanyl | Active comparator | Drug: Standard medical treatmentConscious 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient controlled analgesiaPatient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute | Drug | Patient controlled propofol sedation |
| Standard medical treatmentMidazolam and/or fentanyl given intravenously as needed by endoscopy nurse | Drug | Standard conscious sedation with midazolam and fentanyl |
Primary outcome
Patient satisfaction
Time frame: One hour after the procedure and one week after the procedure
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.
3 secondary outcomes
Recovery time
Time frame: <4 hours post examination
Procedure duration
Time frame: Postprocedure
Adverse events
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Colo-rectal Polyps
RecruitingObservational study
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Zenker Diverticulum, Polyp of Colon
Not yet recruiting
Comparison of the Diagnostic Accuracy Between Three Dimensional and Standard Colonoscopy of Colorectal Polyps
Colo-rectal Polyps, Colonoscopy
RecruitingObservational study
Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
Colorectal Cancer, Adenoma Colon
Not yet recruiting
Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital
Artificial Intelligence, Colonic Adenoma
Recruiting
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
Rectal Cancer, Colo-rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard E Marsk, MD, Docent principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard medical treatment in people with Colo-rectal Polyps, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard E Marsk, MD, Docent (+46 8 123 71956, richard.marsk@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: One hour after the procedure and one week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.