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Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

NCT ID: NCT01594021

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-06-30

Brief Summary

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Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

Detailed Description

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This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to

* a control group that will receive a low preemptive volume loading (50 mL of gelatin),
* a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).

Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.

Conditions

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Anesthesia

Keywords

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propofol anesthesia, induction hypotension cardiac output

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High pre-emptive volume loading

Group Type EXPERIMENTAL

Gelatin 500 mL

Intervention Type DRUG

intravenous administration

Low pre-emptive volume loading

Group Type ACTIVE_COMPARATOR

Gelatin 50 mL

Intervention Type DRUG

intravenous administration

Interventions

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Gelatin 500 mL

intravenous administration

Intervention Type DRUG

Gelatin 50 mL

intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing elective surgery.

Exclusion Criteria

* Difficult peripheral venous access
* Allergy to gelatin
* Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
* Morbid obesity, low BMI,
* hypovolemia,
* Raynaud syndrome or scleroderma,
* Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
* Hematocrit \< 20%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgan Le Guen

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Marc Fischler

Role: STUDY_DIRECTOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00368-35

Identifier Type: OTHER

Identifier Source: secondary_id

2012/13

Identifier Type: -

Identifier Source: org_study_id