Expired Propofol in Low Back Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Device: Edmon

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Torsten Eken, PhD; Phone Number: 004795079939; Email: torsten.eken@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Recruiting
    • Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Edmon arm	Device: Edmon; Exhaled air will be analyzed for propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exhaled air versus plasma concentration	per-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Kristin S Thagaard, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Edmon-Oslo-Low Back Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No