Patient-Controlled Sedation in Port Implantation (PACSPI-2)

Phase 4

Recruiting

Conditions: Pain
Patient Satisfaction
Cancer
Venous Puncture

Registration Number: NCT05688384

Lead Sponsor: Region Jönköping County

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: - Patients =18 years with cancer in need of SVP. 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. - Pregnancy - Previous participation in study

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal intraprocedural pain level on numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Participants overall satisfaction, Participants satisfaction with staff;Number of participants with arterial puncture, pneumothorax, bradycardia, hypoxia, airway intervention, bradypnea;Sedation score on Observers Assessment of Alertness/Sedation scale (OAA/S);type of catheter;amount and type of local anaesthesia;amount of sedative medication given;time consumption of the procedure;number of puncture attempts;use of ultrasound;positioning of catheter tip;vessel choice;Quality of Recovery QoR-15 questionnaire;Quality of Recovery QoR-15 questionnaire;Quality of Recovery QoR-15 questionnaire;Participants evaluation of the importance of receiving sedatives during the procedure Participants evaluation of the importance of being in control of sedation administration