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Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817541
Enrollment
30
Registered
2019-01-25
Start date
2018-11-14
Completion date
2020-12-31
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Cholecystectomy

Brief summary

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

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.

Interventions

DEVICEEdmon (reg), BBraun

exhaled propofol will be compared With plasma propofol values

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
exhaled propofol concentrationstart of anaesthesia to end of anaesthesia, 2-3 hours in totalparts per billion
propofol plasma concentration4-6 samples in the period between start and end of anaesthesiamicrog pr ml

Secondary

MeasureTime frameDescription
calculated effect site concentrationfrom start of anaesthesia until end of anaesthesia, 1-3 hours in totalMarsh model, microg pr ml
calculated plasma concentrationFrom start of anaesthesia until end of anaesthesia, 1-3 hrs in totalMarsh model prediction, microg pr ml
EEG Power distributionfrom start of anaesthesia until end of anaesthesia, 1-3 hours in total% representation relative Power of Alpha, Beta, Theta, Gamma band
EEG Power spectrumfSpectral edge value (Hz)
BISfrom start of anaesthesia until end of anaestheisa, 1-3 hours in totalBispectral index value, score = 0-100

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026