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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03283410
• Other study ID #: CAEE 41471115.1.0000.5558
• Status: Withdrawn
• Phase: Phase 4
• First received: May 29, 2015
• Last updated: September 12, 2017
• Start date: January 30, 2017
• Est. completion date: January 30, 2017

Study information

• Verified date: September 2017
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
Propofol plasmatic concentration (Marsh)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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