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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2017-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single Study Arm

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol plasmatic concentration (Marsh)

Interventions

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Propofol

Propofol plasmatic concentration (Marsh)

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes