- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631393
Patient-controlled Sedation in Port Implantation (PACSPI-1) (PACSPI-1)
Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Jönköping, Sweden, 55185
- Länssjukhuset Ryhov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants maximal pain level
Time Frame: 10 minutes before discharge from recovery area
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural time consumption
Time Frame: after completion of procedure
|
From procedure start (local anesthesia injection) until end of procedure (last suture).
|
after completion of procedure
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Delivered doses of propofol and alfentanil
Time Frame: after completion of procedure
|
The total dose of given sedation and analgesia.
|
after completion of procedure
|
Grading of implantation conditions by the implanting physician
Time Frame: after completion of procedure
|
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
Time Frame: 10 minutes before discharge from recovery area
|
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
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10 minutes before discharge from recovery area
|
Participants satisfaction with staff
Time Frame: 10 minutes before discharge from recovery area
|
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
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10 minutes before discharge from recovery area
|
Participants maximal pain from arm where infusion is
Time Frame: 10 minutes before discharge from recovery area
|
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
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Participants satisfaction with pain treatment during implantation
Time Frame: 10 minutes before discharge from recovery area
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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
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10 minutes before discharge from recovery area
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Participants evaluation of the importance of receiving sedatives during the procedure
Time Frame: 10 minutes before discharge from recovery area
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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
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10 minutes before discharge from recovery area
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Participants evaluation of the importance of being in control of sedation administration
Time Frame: 10 minutes before discharge from recovery area
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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
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10 minutes before discharge from recovery area
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial puncture
Time Frame: after completion of procedure
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Physicians assessment after completion of procedure.
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after completion of procedure
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Pneumothorax
Time Frame: after completion of procedure
|
Physicians assessment after completion of procedure.
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after completion of procedure
|
Bradycardia
Time Frame: after completion of procedure
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Defined as heart < 40/minutes during the procedure
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after completion of procedure
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Hypoxia
Time Frame: after completion of procedure
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Defined as Oxygen saturation <90% or significant drop from baseline (>5% SaO2 drop) during the procedure
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after completion of procedure
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Airway intervention (Chin lift)
Time Frame: after completion of procedure
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Defined as intervention by staff with chin lift during the procedure
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after completion of procedure
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Respiratory rate
Time Frame: after completion of procedure
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Defined as respiratory rate <8/minute during the procedure
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after completion of procedure
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Sedation score at time points T1-T4
Time Frame: during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal
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Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS
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during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Margaretha Stenmarker, MD, PhD, Region Jonkoping County
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPM 2020-02642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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