Determination of serum paracetamol concentration with an electrochemical measurement tool from blood and saliva samples in patients using also other medication.

Phase 1

Active, not recruiting

• Conditions: Patients with any medical condition that requires regular medication and who are undergoing elective surgery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-000360-30-FI
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 18-75 yrs
At least one medical condition that requires regular medication (American Society of Anesthesiology (ASA) Classification 2-4)
Elective surgery, planned premedication with paracetamol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Age under 18 or over 76 yrs.
Pregnancy, lactation.
Prisoner
Alcohol abuse
Liver disease that prevents use of paracetamol as premedication for surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We have previously validated a novel electrochemical paracetamol concentration measurement sensor in vivo and in healthy volunteers. <br>Other medication can possibly cause disturbance in electrochemical analysis. Objective of this trial is to validate this novel sensor in patients who use other, possibly confounding medication. ;Secondary Objective: Saliva is a promising matrix in paracetamol concentration measurement. We will find out if paracetamol concentration measurement in saliva is reliable compared to measurement in plasma in patients who use confounding medication. ;Primary end point(s): Paracetamol concentration measurement with novel electrochemical sensor, gold standard mass-spectrometry and/or standard photometric method. ;Timepoint(s) of evaluation of this end point: 0.5-4 h after administration of paracetamol.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Paracetamol concentration measurement in saliva, compared to concentration measured in plasma. ;Timepoint(s) of evaluation of this end point: 0,5- 4h after administration of paracetamol