Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Not Applicable

• Conditions: Cholecystectomy; Bariatric Surgery Candidate
• Interventions: Device: Edmon (reg), BBraun

• Registration Number: NCT03817541
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Edmon (reg), BBraun	Patients due for bariatric surgery, BMI \> 30
Cholecystectomy	Edmon (reg), BBraun	Normal weight patients due for cholecystectomies

Primary Outcome Measures

Name	Time	Method
exhaled propofol concentration	start of anaesthesia to end of anaesthesia, 2-3 hours in total	parts per billion
propofol plasma concentration	4-6 samples in the period between start and end of anaesthesia	microg pr ml

Secondary Outcome Measures

Name	Time	Method
calculated plasma concentration	From start of anaesthesia until end of anaesthesia, 1-3 hrs in total	Marsh model prediction, microg pr ml
BIS	from start of anaesthesia until end of anaestheisa, 1-3 hours in total	Bispectral index value, score = 0-100
calculated effect site concentration	from start of anaesthesia until end of anaesthesia, 1-3 hours in total	Marsh model, microg pr ml
EEG Power spectrum	f	Spectral edge value (Hz)
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

Trial Locations

Locations (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway