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

September 12, 2017 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Study Arm
All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.
Drug: Propofol
Propofol plasmatic concentration (Marsh)
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIS value greater than 60 or lower than 40 during general anesthesia
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2017

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEE 41471115.1.0000.5558

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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