NCT01248234

Brief Summary

This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

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withdrawn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

November 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

Same day

First QC Date

November 23, 2010

Last Update Submit

July 12, 2012

Conditions

Hypertension

Keywords

elderlyhypertensiveanesthesia

Outcome Measures

Primary Outcomes (1)

  • Blood pressure stability during anesthetic induction

    Blood pressure will be measures every minute for 15 minutes following anesthetic induction

    15 minutes

Study Arms (3)

Propofol

ACTIVE COMPARATOR

Propofol alone will be used to put an elderly hypertensive patient to sleep for surgery.

Drug: propofol

Etomidate

ACTIVE COMPARATOR

Etomidate alone will be used to put an elderly hypertensive patient to sleep.

Drug: Etomidate

Propofol and Etomidate

ACTIVE COMPARATOR

A combination of Etomidate and Propofol will be used to put an elderly hypertensive patient to sleep for surgery.

Drug: Propofol and Etomidate

Interventions

propofolDRUG

Propofol 1mg/kg will be given once to put the patient to sleep for surgery.

Propofol
EtomidateDRUG

Etomidate 0.3mg/kg will be given once to put the patient to sleep for surgery.

Etomidate
Propofol and EtomidateDRUG

Etomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery.

Propofol and Etomidate

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients at least 65 years old, with a history of hypertension.

You may not qualify if:

  • Patients less than 65 years old or without a history of hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

PropofolEtomidate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cynthia A Vaughn, MD

    University of Mississippi Medical Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 25, 2010

Study Start

July 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

US(1)