NCT04631393

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Stefanie Seifert · Other Government
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Patient Satisfaction

Interventions

Type	Name	Description
DRUG	Propofol Alfentanil	Propofol and Alfentanil are self-administered by the participant.

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2020-11-17
• Last updated: 2021-10-19

Locations

1 site across 1 country: Sweden