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

Stefanie Seifert

Status: Completed

Conditions: Patient Satisfaction; Pain

Treatments: Drug: Propofol Alfentanil

Study type: Observational

Funder types: Other

Identifiers

NCT04631393

EPM 2020-02642

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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