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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Alfentanil | Drug | Propofol and Alfentanil are self-administered by the participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes before discharge from recovery area |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time consumption | From procedure start (local anesthesia injection) until end of procedure (last suture). | after completion of procedure |
| Delivered doses of propofol and alfentanil | The total dose of given sedation and analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial puncture | Physicians assessment after completion of procedure. | after completion of procedure |
| Pneumothorax | Physicians assessment after completion of procedure. |
Inclusion Criteria:
• Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.
Exclusion Criteria:
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Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Margaretha Stenmarker, MD, PhD | Region Jönköping County | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Länssjukhuset Ryhov | Jönköping | 55185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31005243 | Background | 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. | |
| 30295410 |
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All IPD that underlie results in a publication will be available for sharing on request.
The supporting information will be available from november 2020 until 6 months after publication
Requests for sharing IPD that underlie results in a publication can be made to the principal investigator.
The supporting information will be available on researchgate.net during the described time frame.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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) | 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 | 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 | 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 | 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 | 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 | 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 | 10 minutes before discharge from recovery area |
| after completion of procedure |
| Bradycardia | Defined as heart < 40/minutes during the procedure | after completion of procedure |
| Hypoxia | Defined as Oxygen saturation <90% or significant drop from baseline (>5% SaO2 drop) during the procedure | after completion of procedure |
| Airway intervention (Chin lift) | Defined as intervention by staff with chin lift during the procedure | after completion of procedure |
| Respiratory rate | Defined as respiratory rate <8/minute during the procedure | after completion of procedure |
| Sedation score at time points T1-T4 | Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS | during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal |
| 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. |
| 29750696 | Background | 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. |
| 31478938 | Background | 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. |
| 23432403 | Result | 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. |
| 37588584 | Derived | Seifert S, Taxbro K, Hammarskjold F. Patient-Controlled Sedation in Port Implantation (PACSPI 1) - A feasibility trial. BJA Open. 2022 Jul 31;3:100026. doi: 10.1016/j.bjao.2022.100026. eCollection 2022 Sep. |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |