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.
Conditions
Interventions
Product Name: Propofol
Product Code: Propofol
Pharmaceutical Form: Emulsion for injection/infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Region Jönköping, Sweden
Region Östergötland, Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: 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 All exclusion criteria as per implantation team´s assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this multicenter RCT we aim to examine the effect of PCS with propofol and alfentanil on patients´ self-reported pain perception scores, overall satisfaction scores, sedation scores and incidence of adverse events. The primary objective is to determine the efficacy of patient-controlled sedation (PCS) as adjunct to local anaesthesia (LA) on patients´ self-reported pain perception during SVP-implantation. Patients in the treatment arm will undergo SVP-insertion in LA combined with PCS and in the control arm SVP-insertion will be conducted in LA.;Secondary Objective: The secondary objectives are analysis of patient distress and satisfaction as well as secondary efficacy outcomes and determination of the relative safety of the treatment arm on defined safety outcomes and all adverse events and costs. ;Primary end point(s): Primary endpoint: The primary endpoint is assessment of patient-reported pain perception. Endpoints are assessed by the use of the numeric rating scale (NRS): •Maximal intraprocedural pain level on NRS ;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated after the patient has received his /her subcutaneous venous port befor discharge home from the postoperative unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • satisfaction with pain treatment during implantation • maximal distress level • importance of receiving sedatives during implantation • overall satisfaction • overall satisfaction with the staff • maximal pain from arm with PCS infusion • importance of being in control of sedation administration • grading of implantation conditions by the implanting physician • perioperative and procedural time consumption • delivered doses of alfentanil and propofol • rescue-therapy by nurse • differences in cost Safety endpoints: • arterial puncture • pneumothorax • hypotension • arrhythmia • hypoxia • airway intervention • respiratory rate ;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluted pre-, intra- and postprocedurally. Evaluation will begin when the patient arrives to the preoperative unit and will end with discharge from the postoperative unit. | — |
Countries
Sweden
Contacts
Public ContactOP/IVA kliniken
OP/IVA kliniken, Länssjukhuset Ryhov, Jönköping, Sweden
Outcome results
None listed