Expired Propofol in Low Back Surgery

University of Oslo (UIO)

Status: Enrolling

Conditions: Anesthesia

Treatments: Device: Edmon

Study type: Interventional

Funder types: Other

Identifiers

NCT04771702

Edmon-Oslo-Low Back Surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Edmon arm

Experimental group

Treatment:

Device: Edmon