Patient-controlled Sedation in Port Implantation (PACSPI-1)

Study Overview
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Brief Summary
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The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).

Detailed Description
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The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation. 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.

Official Title
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Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial

Conditions
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Pain, Patient Satisfaction

Intervention / Treatment
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* Drug: Propofol Alfentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital. Exclusion Criteria: Inability to operate the PCS apparatus, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol Alfentanil|Propofol and Alfentanil are self-administered by the participant.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants maximal pain level | Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire. | 10 minutes before discharge from recovery area | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time consumption | From procedure start (local anesthesia injection) until end of procedure (last suture). | after completion of procedure | 
| Delivered doses of propofol and alfentanil | The total dose of given sedation and analgesia. | after completion of procedure | 
| Grading of implantation conditions by the implanting physician | The port-implanting physicians assessment of implantation conditions during the procedure on a numeric rating scale (0=worst possible, 10= best possible) | after completion of procedure | 
| Participants overall satisfaction | Participants assessment of overall satisfaction experienced during the procedure using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire | 10 minutes before discharge from recovery area | 
| Participants satisfaction with staff | Participants assessment of satisfaction with the staff using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire | 10 minutes before discharge from recovery area | 
| Participants maximal pain from arm where infusion is | Participants assessment of pain from arm with the infusion using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire | 10 minutes before discharge from recovery area | 
| Participants satisfaction with pain treatment during implantation | Participants assessment of satisfaction with pain treatment on a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire | 10 minutes before discharge from recovery area | 
| Participants evaluation of the importance of receiving sedatives during the procedure | Participants assessment of the importance of receiving sedatives on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire | 10 minutes before discharge from recovery area | 
| Participants evaluation of the importance of being in control of sedation administration | Participants assessment of the importance of being in control of sedation administration on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire | 10 minutes before discharge from recovery area | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-controlled sedation, totally implantable venous access devices, subcutaneous implanted venous port, local anesthesia, propofol, alfentanil, indwelling catheter