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

Brasilia University Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Anesthesia

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03283410

CAEE 41471115.1.0000.5558

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Study Arm

Experimental group

Description:

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

Treatment:

Drug: Propofol