NCT03283410

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

May 29, 2015

Last Update Submit

September 12, 2017

Conditions

Anesthesia

Keywords

propofoldose-responseelderlyyoung adults

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

PropofolDRUG

Propofol plasmatic concentration (Marsh)

Also known as: Diprivan
Single Study Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gabriel MN Guimaraes, MsC

    Professor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

May 29, 2015

First Posted

September 14, 2017

Study Start

January 30, 2017

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09