An observational study in Pain and Patient Satisfaction, sponsored by Stefanie Seifert. Completed at 1 site in Sweden. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Stefanie Seifert · Observational
The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).
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.
This is the only study on the registry with Stefanie Seifert as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.
Exclusion Criteria:
Propofol and Alfentanil are self-administered by the participant.
Also known as: Propofol/Alfentanil self-administration
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.
Time frame: 10 minutes before discharge from recovery area
Procedural time consumption
From procedure start (local anesthesia injection) until end of procedure (last suture).
Time frame: after completion of procedure
Delivered doses of propofol and alfentanil
The total dose of given sedation and analgesia.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 minutes before discharge from recovery area
Arterial puncture
Physicians assessment after completion of procedure.
Time frame: after completion of procedure
Pneumothorax
Physicians assessment after completion of procedure.
Time frame: after completion of procedure
Bradycardia
Defined as heart \< 40/minutes during the procedure
Time frame: after completion of procedure
Hypoxia
Defined as Oxygen saturation \<90% or significant drop from baseline (\>5% SaO2 drop) during the procedure
Time frame: after completion of procedure
Airway intervention (Chin lift)
Defined as intervention by staff with chin lift during the procedure
Time frame: after completion of procedure
Respiratory rate
Defined as respiratory rate \<8/minute during the procedure
Time frame: after completion of procedure
Sedation score at time points T1-T4
Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS
Time frame: during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal
Plan to share: Yes — All IPD that underlie results in a publication will be available for sharing on request.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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