Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients

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

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery Candidate; Cholecystectomy
• Intervention / Treatment: Device: Edmon (reg), BBraun

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Recruiting
    • Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Expiratory propofol gastro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No