Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Stefanie Seifert
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Participants maximal pain level
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Stefanie Seifert
Principal Investigator
Region Jönköping County
Eligibility Criteria
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
Outcomes
Primary Outcomes
Participants maximal pain level
Time Frame: 10 minutes before discharge from recovery area
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.
Secondary Outcomes
- Participants maximal pain from arm where infusion is(10 minutes before discharge from recovery area)
- Procedural time consumption(after completion of procedure)
- Delivered doses of propofol and alfentanil(after completion of procedure)
- Grading of implantation conditions by the implanting physician(after completion of procedure)
- Participants overall satisfaction(10 minutes before discharge from recovery area)
- Participants satisfaction with staff(10 minutes before discharge from recovery area)
- Participants satisfaction with pain treatment during implantation(10 minutes before discharge from recovery area)
- Participants evaluation of the importance of receiving sedatives during the procedure(10 minutes before discharge from recovery area)
- Participants evaluation of the importance of being in control of sedation administration(10 minutes before discharge from recovery area)