NCT03817541

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

January 18, 2019

Last Update Submit

February 2, 2019

Conditions

Bariatric Surgery CandidateCholecystectomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • calculated plasma concentration

    From start of anaesthesia until end of anaesthesia, 1-3 hrs in total

  • BIS

    from start of anaesthesia until end of anaestheisa, 1-3 hours in total

  • calculated effect site concentration

    from start of anaesthesia until end of anaesthesia, 1-3 hours in total

  • EEG Power spectrum

    f

  • EEG Power distribution

    from start of anaesthesia until end of anaesthesia, 1-3 hours in total

Study Arms (2)

Bariatric surgery

EXPERIMENTAL

Patients due for bariatric surgery, BMI \> 30

Device: Edmon (reg), BBraun

Cholecystectomy

EXPERIMENTAL

Normal weight patients due for cholecystectomies

Device: Edmon (reg), BBraun

Interventions

Edmon (reg), BBraunDEVICE

exhaled propofol will be compared With plasma propofol values

Also known as: propofol plasma sample
Bariatric surgeryCholecystectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 25, 2019

Study Start

November 14, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2020

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

NO(1)