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WithdrawnNCT03283410Updated Sep 14, 2017

Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis

A Phase 4 interventional study of Propofol in Anesthesia, sponsored by Brasilia University Hospital. Withdrawn. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Brasilia University Hospital · Phase 4, Interventional, and Supportive care

Why this study was withdrawn
Local problems with BIS monitor, we wont have it anymore.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.

Read the detailed description

Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.

02

Conditions studied

  • Anesthesia

Keywords

  • propofol
  • dose-response
  • elderly
  • young adults
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Both sex
  • Between 18-28 or 65-75 years old
  • ASA physical status I or II
  • no pre-anesthetic medications prescribed
  • scheduled for surgery under general anesthesia
  • willing to participate and sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • Contraindications for propofol usage
  • history of neurologic or psychiatric diseases
  • drug abusers
  • users of drugs that alter central nervous system
  • pregnancy
  • emergency surgeries
  • rapid sequence intubation.
04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Single Study Arm

    All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.

    Drug: Propofol

Interventions

  • DrugPropofol

    Propofol plasmatic concentration (Marsh)

    Also known as: Diprivan

05

What researchers measure

Primary outcomes

  1. BIS value greater than 60 or lower than 40 during general anesthesia

    BIS value greater than 60 or lower than 40 during general anesthesia

    Time frame: BIS value greater than 60 or lower than 40 during general anesthesia

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03283410
Lead sponsor
Brasilia University Hospital
Responsible party
Gabriel Magalhaes Nunes Guimaraes (Head of Anesthesiology, Brasilia University Hospital) — Principal investigator
First posted
Sep 14, 2017
Start date
Jan 30, 2017
Primary completion
Jan 30, 2017
Completion
Jan 30, 2017
Last update
Sep 14, 2017

Study contacts

Gabriel MN Guimaraes, MsC
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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