Determination of Propofol Target Concentration for Young... | NCT03283410

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

NCT03283410

Sponsor

Brasilia University Hospital

Status

Withdrawn

Last Update Posted

Sep 14, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Anesthesia

Interventions

Propofol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Local problems with BIS monitor, we wont have it anymore.

Expanded Access Info

Start Date

Jan 30, 2017Actual

Primary Completion Date

Jan 30, 2017Actual

Completion Date

Jan 30, 2017Actual

First Submitted Date

May 29, 2015

First Submission Date that Met QC Criteria

Sep 12, 2017

First Posted Date

Sep 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2017

Last Update Posted Date

Sep 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesiology, Brasilia University HospitalPrincipal Investigator

Lead Sponsor

Brasilia University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Study Arm	Experimental	All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Propofol plasmatic concentration (Marsh)	Single Study Arm

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gabriel MN Guimaraes, MsC	Professor	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided