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

NCT05688384 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-11-12

No results posted yet for this study

Summary

The goal of the study is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces patient-reported pain perception during implantation of subcutaneous venous port (SVP).

The main question it aims to answer: How much pain did you (patient) experience during SVP-implantation Several other questions will be answered regarding: patient´s perception of the procedure, complication rate, procedure data.

The study contains two groups which will be compared. Control group: will do SVP implantation under local anaesthesia Study group: will do SVP implantation under local anaesthesia and patient-controlled sedation.

The patients are asked to complete a questionnaire postoperatively which contains questions on pain perception and satisfaction.

Conditions

  • Pain
  • Patient Satisfaction
  • Cancer
  • Venous Puncture

Interventions

DRUG

Propofol + Alfentanil

In addition to LA, patients in the study group are able to self-administer a combination of propofol and alfentanil using a patient-controlled sedation pump. The pump enables the patient via a hand-held button to trigger the release of a single bolus of 0.5ml containing 4.5mg propofol and 25µg alfentanil under an 10second period. This results in a maximal possible amount of 6 bolus doses per minute.

Sponsors & Collaborators

  • Region Östergötland

    collaborator OTHER

  • Region Jönköping County

    lead OTHER_GOV

Principal Investigators

  • Stefanie Seifert · Region Jönköping

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2024-11-08
Completion
2024-11-08

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688384 on ClinicalTrials.gov