CompletedNot Applicable

Patient-controlled Sedation in Port Implantation (PACSPI-1)

Sweden40 participantsStarted 2021-04-14

Plain-language summary

The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).

Who can participate

Age range

18 Years – 105 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: • Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital. Exclusion Criteria: * Inability to operate the PCS apparatus, * Inability to communicate in Scandinavian languages. * Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea). * Propofol or alfentanil allergy. * Intake of food (or clear fluids) within six (or two) hours prior to the procedure. * Failure to achieve peripheral vascular access. * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants maximal pain level

Timeframe: 10 minutes before discharge from recovery area

Trial details

NCT IDNCT04631393

SponsorStefanie Seifert

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-10-15

View on ClinicalTrials.gov More Pain trials

Who can participate

Age range

18 Years – 105 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.