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Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Sponsor
Oslo University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03817541
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
25.6
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Edmon (reg), BBraun
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomyOne Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients
Actual Study Start Date :
Nov 14, 2018
Anticipated Primary Completion Date :
Jun 30, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bariatric surgery

Patients due for bariatric surgery, BMI > 30

Device: Edmon (reg), BBraun
exhaled propofol will be compared With plasma propofol values
Other Names:
  • propofol plasma sample

    		•
    Experimental: Cholecystectomy

    Normal weight patients due for cholecystectomies

    Device: Edmon (reg), BBraun
    exhaled propofol will be compared With plasma propofol values
    Other Names:
  • propofol plasma sample

    		•

    Outcome Measures

    Primary Outcome Measures

    1. exhaled propofol concentration [start of anaesthesia to end of anaesthesia, 2-3 hours in total]

      parts per billion

    2. propofol plasma concentration [4-6 samples in the period between start and end of anaesthesia]

      microg pr ml

    Secondary Outcome Measures

    1. calculated plasma concentration [From start of anaesthesia until end of anaesthesia, 1-3 hrs in total]

      Marsh model prediction, microg pr ml

    2. BIS [from start of anaesthesia until end of anaestheisa, 1-3 hours in total]

      Bispectral index value, score = 0-100

    3. calculated effect site concentration [from start of anaesthesia until end of anaesthesia, 1-3 hours in total]

      Marsh model, microg pr ml

    4. EEG Power spectrum [f]

      Spectral edge value (Hz)

    5. EEG Power distribution [from start of anaesthesia until end of anaesthesia, 1-3 hours in total]

      % representation relative Power of Alpha, Beta, Theta, Gamma band

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Anesthesiology, Oslo University Hospital, Ullevaal Oslo Norway 0407

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johan C Ræder, Professor, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03817541
    Other Study ID Numbers:
    • Expiratory propofol gastro
    First Posted:
    Jan 25, 2019
    Last Update Posted:
    Feb 5, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Propofol

    Study Results

    No Results Posted as of Feb 5, 2019