Clinical trial NCT04631393: Patient-controlled Sedation in Port Implantation (PACSPI-1)
Official title: Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Patient Satisfaction
Keywords: patient-controlled sedation
totally implantable venous access devices
subcutaneous implanted venous port
local anesthesia
propofol
alfentanil
indwelling catheter
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
First posted: 2020-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.

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.

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

Primary outcomes:
measure: Participants maximal pain level
timeFrame: 10 minutes before discharge from recovery area
Secondary outcomes:
measure: Procedural time consumption
timeFrame: after completion of procedure
measure: Delivered doses of propofol and alfentanil
timeFrame: after completion of procedure
measure: Grading of implantation conditions by the implanting physician
timeFrame: after completion of procedure
measure: Participants overall satisfaction
timeFrame: 10 minutes before discharge from recovery area
measure: Participants satisfaction with staff
timeFrame: 10 minutes before discharge from recovery area
measure: Participants maximal pain from arm where infusion is
timeFrame: 10 minutes before discharge from recovery area
measure: Participants satisfaction with pain treatment during implantation
timeFrame: 10 minutes before discharge from recovery area
measure: Participants evaluation of the importance of receiving sedatives during the procedure
timeFrame: 10 minutes before discharge from recovery area
measure: Participants evaluation of the importance of being in control of sedation administration
timeFrame: 10 minutes before discharge from recovery area
Other outcomes:
measure: Arterial puncture
timeFrame: after completion of procedure
measure: Pneumothorax
timeFrame: after completion of procedure
measure: Bradycardia
timeFrame: after completion of procedure
measure: Hypoxia
timeFrame: after completion of procedure
measure: Airway intervention (Chin lift)
timeFrame: after completion of procedure
measure: Respiratory rate
timeFrame: after completion of procedure
measure: Sedation score at time points T1-T4
timeFrame: during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal
Locations:
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
Study officials:
affiliation: Region Jönköping County
name: Margaretha Stenmarker, MD, PhD
role: STUDY_CHAIR
References:
citation: Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
citation: Clements W, Sneddon D, Kavnoudias H, Joseph T, Goh GS, Koukounaras J, Snow T. Randomized and controlled study comparing patient controlled and radiologist controlled intra-procedural conscious sedation, using midazolam and fentanyl, for patients undergoing insertion of a central venous line. J Med Imaging Radiat Oncol. 2018 Dec;62(6):781-788. doi: 10.1111/1754-9485.12817. Epub 2018 Oct 8.
citation: Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.
citation: Grossmann B, Nilsson A, Sjoberg F, Nilsson L. Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Apr;27(2):77-85. doi: 10.1097/LBR.0000000000000610.
citation: Taxbro K, Berg S, Hammarskjold F, Hanberger H, Malmvall BE. A prospective observational study on 249 subcutaneous central vein access ports in a Swedish county hospital. Acta Oncol. 2013 Jun;52(5):893-901. doi: 10.3109/0284186X.2013.770601. Epub 2013 Feb 22.