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

Phase 4

Withdrawn

• Conditions: Anesthesia
• Interventions: Drug: Propofol

• Registration Number: NCT03283410
• Lead Sponsor: Brasilia University Hospital

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2017-01-30
• Primary Completion: 2017-01-30
• Study Completion: 2017-01-30
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Study Arm	Propofol	All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.

Primary Outcome Measures

Name	Time	Method
BIS value greater than 60 or lower than 40 during general anesthesia	BIS value greater than 60 or lower than 40 during general anesthesia	BIS value greater than 60 or lower than 40 during general anesthesia