EUCTR2021-003821-31-SE
Active, not recruiting
Phase 1
Patient-controlled Sedation in Port Implantation (PACSPI 2)- a randomized controlled trial
Region Jönköping, Sweden0 sites340 target enrollmentJanuary 11, 2022
ConditionsPatients =18 years with cancer in need of subcutaneous venous port will be offered to participate in the trial. The aim of the trial is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces pain perception during implantation of subcutaneous venous port (SVP) in cancer patients.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients =18 years with cancer in need of subcutaneous venous port will be offered to participate in the trial. The aim of the trial is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces pain perception during implantation of subcutaneous venous port (SVP) in cancer patients.
- Sponsor
- Region Jönköping, Sweden
- Enrollment
- 340
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients (\=18 years) with cancer scheduled for SVP\-implantation at participating anaesthesia departments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 170
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 170
Exclusion Criteria
- •Inability to operate the PCS apparatus,
- •Inability to communicate in Scandinavian languages.
- •Patients who require general anaesthesia or patients eligible for LA only on anesthesiologist´s assessment (i.e. severe sleep apnea).
- •Propofol or alfentanil allergy.
- •Non\-fasting according to guidelines of the Swedish Society for Anaesthesia and Intensive Care (SFAI).
- •Failure to achieve peripheral vascular access.
- •Previous participation in study
- •All exclusion criteria as per implantation team´s assessment.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Patient-controlled Sedation in Port Implantation (PACSPI-1)PainPatient SatisfactionNCT04631393Stefanie Seifert40
Completed
Phase 4
Patient-Controlled Sedation in Port Implantation (PACSPI-2)PainPatient SatisfactionCancerVenous PunctureNCT05688384Region Jönköping County340
Recruiting
Not Applicable
Development of patient controlled sedation protocol according to changes of EEG parameter during dental treatmentNot ApplicableKCT0001618Seoul National University Dental Hospital60
Recruiting
Not Applicable
protocolized sedation vs non-protocolized sedation in mechanically ventilated patients.Health Condition 1: O- Medical and SurgicalCTRI/2021/04/033130pujitha vallabhaneni
Active, not recruiting
Not Applicable
Sedation during routine procedural sedation in the pediatric intensive care unit - clinical vs. technical measurement of sedation depthdepth of sedationDRKS00024075niversitätsklinikum EssenKlinik für Kinderheilkunde I23