Expired Propofol in Low Back Surgery

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Device: Edmon

• Registration Number: NCT04771702
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-01-13
• Study Start: 2021-01-14
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25
• Primary Completion: 2022-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Edmon arm	Edmon	-

Primary Outcome Measures

Name	Time	Method
Exhaled air versus plasma concentration	per-operative

Secondary Outcome Measures

Name	Time	Method
Exhaled propofol 2	per-operative	Exhaled propofol versus dose given, estimated plasma concentration, estimated effect site concentration
Nociceptive stimulation	per-operative	Skin conductance versus plasma and exhaled propofol concentration
EEG recording	per-operative	EEG will be recorded and compared with plasma propofol, exhaled propofol and BIS

Trial Locations

Locations (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway