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

Pain Clinical Trial

— PACSPI-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631393
• Other study ID #: EPM 2020-02642
• Status: Completed
• Start date: April 14, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2021
• Source: Region Jönköping County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Patient Satisfaction

Intervention

Drug:
• Propofol Alfentanil
Propofol and Alfentanil are self-administered by the participant.

Locations

Country	Name	City	State
Sweden	Länssjukhuset Ryhov	Jönköping

Sponsors (1)

Lead Sponsor	Collaborator
Stefanie Seifert

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

Grossmann B, Nilsson A, Sjöberg 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. — View Citation

Kreienbühl L, Elia N, Pfeil-Beun E, Walder B, Tramèr 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. — View Citation

Taxbro K, Berg S, Hammarskjöld 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 — View Citation

Taxbro K, Hammarskjöld 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial puncture	Physicians assessment after completion of procedure.	after completion of procedure
Other	Pneumothorax	Physicians assessment after completion of procedure.	after completion of procedure
Other	Bradycardia	Defined as heart < 40/minutes during the procedure	after completion of procedure
Other	Hypoxia	Defined as Oxygen saturation <90% or significant drop from baseline (>5% SaO2 drop) during the procedure	after completion of procedure
Other	Airway intervention (Chin lift)	Defined as intervention by staff with chin lift during the procedure	after completion of procedure
Other	Respiratory rate	Defined as respiratory rate <8/minute during the procedure	after completion of procedure
Other	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
Primary	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	Procedural time consumption	From procedure start (local anesthesia injection) until end of procedure (last suture).	after completion of procedure
Secondary	Delivered doses of propofol and alfentanil	The total dose of given sedation and analgesia.	after completion of procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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