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Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

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ClinicalTrials.gov Identifier: NCT03817541
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

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
Bariatric Surgery Candidate Cholecystectomy Device: Edmon (reg), BBraun Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : November 14, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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 Name: 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 Name: propofol plasma sample




Primary Outcome Measures :
  1. exhaled propofol concentration [ Time Frame: start of anaesthesia to end of anaesthesia, 2-3 hours in total ]
    parts per billion

  2. propofol plasma concentration [ Time Frame: 4-6 samples in the period between start and end of anaesthesia ]
    microg pr ml


Secondary Outcome Measures :
  1. calculated plasma concentration [ Time Frame: From start of anaesthesia until end of anaesthesia, 1-3 hrs in total ]
    Marsh model prediction, microg pr ml

  2. BIS [ Time Frame: from start of anaesthesia until end of anaestheisa, 1-3 hours in total ]
    Bispectral index value, score = 0-100

  3. calculated effect site concentration [ Time Frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total ]
    Marsh model, microg pr ml

  4. EEG Power spectrum [ Time Frame: f ]
    Spectral edge value (Hz)

  5. EEG Power distribution [ Time Frame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total ]
    % representation relative Power of Alpha, Beta, Theta, Gamma band



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817541


Locations
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Norway
Dept of Anesthesiology, Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0407
Contact: Johan Raeder    +47 92249669    johan.rader@medisin.uio.no   
Principal Investigator: Johan Raeder         
Sponsors and Collaborators
Oslo University Hospital

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Responsible Party: Johan C Ræder, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03817541     History of Changes
Other Study ID Numbers: Expiratory propofol gastro
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics