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NCT04771702 Clinical Trial

Expired Propofol in Low Back Surgery

Anesthesia Clinical Trial

Official title:
Propofol Measurement in Expiration Air and Monitoring of EEG and Pain in Patients Undergoing Low Back Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04771702
Other study ID # Edmon-Oslo-Low Back Surgery
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2021
Est. completion date December 2024

Study information
Verified date February 2021
Source Oslo University Hospital
Contact Johan Raeder, PhD
Phone 004792249669
Email johan.rader@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air. The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.

Description:

Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil. After induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance. After start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Elective patients scheduled for low-back surgery - BMI between 20 -32 kg/m2 - ASA I-II - Written informed concent Exclusion Criteria: - Contraindication to propofol TCI - Use of psychopharmaco or neurologic disease - Pregnancy or breast feeding

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Edmon
Exhaled air will be analyzed for propofol

Locations
Country Name City State
Norway Dept of Anesthesiology, Oslo University Hospital, Ullevaal Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exhaled air versus plasma concentration per-operative
Secondary EEG recording EEG will be recorded and compared with plasma propofol, exhaled propofol and BIS per-operative
Secondary Exhaled propofol 2 Exhaled propofol versus dose given, estimated plasma concentration, estimated effect site concentration per-operative
Secondary Nociceptive stimulation Skin conductance versus plasma and exhaled propofol concentration per-operative
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