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

NCT04631393 | Completed

• 1 other identifier: EPM 2020-02642
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Patient Satisfaction

Keywords

patient-controlled sedation; totally implantable venous access devices; subcutaneous implanted venous port; local anesthesia; propofol; alfentanil; indwelling catheter

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Procedural time consumption

  after completion of procedure

• Delivered doses of propofol and alfentanil

  after completion of procedure

• Grading of implantation conditions by the implanting physician

  after completion of procedure

• Participants overall satisfaction

  10 minutes before discharge from recovery area

• Participants satisfaction with staff

  10 minutes before discharge from recovery area

Other Outcomes (7)

• Arterial puncture

  after completion of procedure

• Pneumothorax

  after completion of procedure

• Bradycardia

  after completion of procedure

Interventions

Propofol Alfentanil DRUG

Propofol and Alfentanil are self-administered by the participant.

Also known as: Propofol/Alfentanil self-administration

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.

You may qualify if:

• Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefanie Seifert: lead

Study Sites (1)

Länssjukhuset Ryhov

Jönköping, 55185, Sweden

Location

Related Publications (6)

• 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.

  PMID: 31005243 BACKGROUND

• 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.

  PMID: 30295410 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.

  PMID: 29750696 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.

  PMID: 31478938 BACKGROUND

• 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.

  PMID: 23432403 RESULT

• 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.

  PMID: 37588584 DERIVED

MeSH Terms

Conditions

Pain; Patient Satisfaction

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Margaretha Stenmarker, MD, PhD

  Region Jönköping County

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: April 14, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting information will be available from november 2020 until 6 months after publication
• Access Criteria: 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.

Locations

SE (1)