Expired Propofol in Low Back Surgery

NCT ID: NCT04771702

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Edmon arm

Group Type EXPERIMENTAL

Edmon

Intervention Type DEVICE

Exhaled air will be analyzed for propofol

Interventions

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Edmon

Exhaled air will be analyzed for propofol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johan C Ræder

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin S Thagaard, MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Johan Raeder, PhD

Role: CONTACT

004792249669

Torsten Eken, PhD

Role: CONTACT

004795079939

Facility Contacts

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Johan Raeder

Role: primary

+47 92249669

Other Identifiers

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Edmon-Oslo-Low Back Surgery

Identifier Type: -

Identifier Source: org_study_id

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