Expired Propofol in Low Back Surgery

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04771702

Enrollment

Registered

2021-02-25

Start date

2021-01-14

Completion date

2024-12-31

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DEVICEEdmon

Exhaled air will be analyzed for propofol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

The intervention is to have patients in 20 min stable anaesthesia before start of surgery in order to validate the use of exhaled propofol versus pharmakokinetic modelling and measured plasma concentration

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Exhaled air versus plasma concentration	per-operative

Secondary

Measure	Time frame	Description
EEG recording	per-operative	EEG will be recorded and compared with plasma propofol, exhaled propofol and BIS
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

Countries

Norway

Contacts

Primary ContactJohan Raeder, PhD

johan.rader@medisin.uio.no004792249669

Backup ContactTorsten Eken, PhD

torsten.eken@medisin.uio.no004795079939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026