Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03817541
• Other study ID #: Expiratory propofol gastro
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cholecystectomy

Intervention

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

Locations

Country	Name	City	State
Norway	Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exhaled propofol concentration	parts per billion	start of anaesthesia to end of anaesthesia, 2-3 hours in total
Primary	propofol plasma concentration	microg pr ml	4-6 samples in the period between start and end of anaesthesia
Secondary	calculated plasma concentration	Marsh model prediction, microg pr ml	From start of anaesthesia until end of anaesthesia, 1-3 hrs in total
Secondary	BIS	Bispectral index value, score = 0-100	from start of anaesthesia until end of anaestheisa, 1-3 hours in total
Secondary	calculated effect site concentration	Marsh model, microg pr ml	from start of anaesthesia until end of anaesthesia, 1-3 hours in total
Secondary	EEG Power spectrum	Spectral edge value (Hz)	f
Secondary	EEG Power distribution	% representation relative Power of Alpha, Beta, Theta, Gamma band	from start of anaesthesia until end of anaesthesia, 1-3 hours in total