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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03283410
Other study ID # CAEE 41471115.1.0000.5558
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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