Expired Propofol in Low Back Surgery | NCT04771702

Studies
Expired Propofol in Low Back Surgery

NCT04771702

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Feb 25, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Edmon

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Edmon arm	Experimental		Device: Edmon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Edmon	Device	Exhaled air will be analyzed for propofol	Edmon arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johan Raeder, PhD	Contact	004792249669		johan.rader@medisin.uio.no
Torsten Eken, PhD	Contact	004795079939		torsten.eken@medisin.uio.no

Overall Officials

Name	Affiliation	Role
Kristin S Thagaard, MD	Oslo University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Recruiting	Oslo		0407	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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