Patient-controlled Sedation in Port Implantation (PACSPI-1)
NCT ID: NCT04631393
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2021-04-14
2021-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. This allows the patient to self-control their sedation/analgesia during SVP implantation. The pump enables the patient via a hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.
Each SVP implantation procedure is separated into four time points at which sedation scores are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed by an anaesthesiologist according to hospital protocol.
Participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.
Adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.
The result of this trial will provide guidance for a larger randomized trial (PACSPI-2) comparing several clinically relevant aspects of the use of PCS and local anesthesia (LA) versus LA alone during SVP implantation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Propofol Alfentanil
Propofol and Alfentanil are self-administered by the participant.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
105 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stefanie Seifert
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stefanie Seifert
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Margaretha Stenmarker, MD, PhD
Role: STUDY_CHAIR
Region Jönköping County
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Länssjukhuset Ryhov
Jönköping, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
Clements W, Sneddon D, Kavnoudias H, Joseph T, Goh GS, Koukounaras J, Snow T. Randomized and controlled study comparing patient controlled and radiologist controlled intra-procedural conscious sedation, using midazolam and fentanyl, for patients undergoing insertion of a central venous line. J Med Imaging Radiat Oncol. 2018 Dec;62(6):781-788. doi: 10.1111/1754-9485.12817. Epub 2018 Oct 8.
Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.
Grossmann B, Nilsson A, Sjoberg F, Nilsson L. Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Apr;27(2):77-85. doi: 10.1097/LBR.0000000000000610.
Taxbro K, Berg S, Hammarskjold F, Hanberger H, Malmvall BE. A prospective observational study on 249 subcutaneous central vein access ports in a Swedish county hospital. Acta Oncol. 2013 Jun;52(5):893-901. doi: 10.3109/0284186X.2013.770601. Epub 2013 Feb 22.
Seifert S, Taxbro K, Hammarskjold F. Patient-Controlled Sedation in Port Implantation (PACSPI 1) - A feasibility trial. BJA Open. 2022 Jul 31;3:100026. doi: 10.1016/j.bjao.2022.100026. eCollection 2022 Sep.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPM 2020-02642
Identifier Type: -
Identifier Source: org_study_id