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Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Unknown

Conditions

Cholecystectomy
Bariatric Surgery Candidate

Treatments

Device: Edmon (reg), BBraun

Study type

Interventional

Funder types

Other

Identifiers

NCT03817541
Expiratory propofol gastro

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Bariatric surgery
Experimental group
Description:
Patients due for bariatric surgery, BMI \> 30
Treatment:
Device: Edmon (reg), BBraun
Cholecystectomy
Experimental group
Description:
Normal weight patients due for cholecystectomies
Treatment:
Device: Edmon (reg), BBraun

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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