Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

NCT ID: NCT03817541

Last Updated: 2019-02-05

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2020-12-31

Brief Summary

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Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol

Detailed Description

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Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.

The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.

The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.

Plasma samples of propofol will be taken for comparison With exhaled propofol.

Conditions

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Bariatric Surgery Candidate Cholecystectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

Patients due for bariatric surgery, BMI \> 30

Group Type EXPERIMENTAL

Edmon (reg), BBraun

Intervention Type DEVICE

exhaled propofol will be compared With plasma propofol values

Cholecystectomy

Normal weight patients due for cholecystectomies

Group Type EXPERIMENTAL

Edmon (reg), BBraun

Intervention Type DEVICE

exhaled propofol will be compared With plasma propofol values

Interventions

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Edmon (reg), BBraun

exhaled propofol will be compared With plasma propofol values

Intervention Type DEVICE

Other Intervention Names

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propofol plasma sample

Eligibility Criteria

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Inclusion Criteria

* • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.

* Both genders.
* Age 18-60 years, both inclusive.
* BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI \> 40
* ASA classification I-III

Exclusion Criteria

* • Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.

* Patients which during a preoperative visit are deemed not to tolerate propofol bolus or infusion as administered by Target Controlled Infusion.
* Ongoing neuroleptic medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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

Locations

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Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Facility Contacts

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Johan Raeder

Role: primary

+47 92249669

Other Identifiers

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Expiratory propofol gastro

Identifier Type: -

Identifier Source: org_study_id

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