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Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia (NICOM-MAP)

Primary Purpose

Anesthesia

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Gelatin 500 mL

Gelatin 50 mL

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring propofol, anesthesia, induction, hypotension, cardiac output

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High pre-emptive volume loading

Low pre-emptive volume loading

Arm Description

Outcomes

Primary Outcome Measures

Hypotension

mean arterial pressure less than 70% of the baseline measurement

Secondary Outcome Measures

hemodynamic effect of leg passive elevation test

hemodynamic effect of volume loading

heart rate monitoring

propofol dose when bispectral index is 50

propofol site effect concentration when bispectral index is 50

arterial pressure monitoring

Full Information

NCT ID

NCT01594021

First Posted

May 5, 2012

Last Updated

October 28, 2016

Sponsor

Hopital Foch

1. Study Identification

Unique Protocol Identification Number

NCT01594021

Brief Title

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

Acronym

NICOM-MAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

Difficulty of realization of the study

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hopital Foch

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia

Keywords

propofol, anesthesia, induction, hypotension, cardiac output

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High pre-emptive volume loading

Arm Type

Experimental

Arm Title

Low pre-emptive volume loading

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Gelatin 500 mL

Intervention Description

intravenous administration

Intervention Type

Drug

Intervention Name(s)

Gelatin 50 mL

Intervention Description

intravenous administration

Primary Outcome Measure Information:

Title

Hypotension

Description

mean arterial pressure less than 70% of the baseline measurement

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

hemodynamic effect of leg passive elevation test

Time Frame

30 minutes

Title

hemodynamic effect of volume loading

Time Frame

30 minutes

Title

heart rate monitoring

Time Frame

30 minutes

Title

propofol dose when bispectral index is 50

Time Frame

30 minutes

Title

propofol site effect concentration when bispectral index is 50

Time Frame

30 minutes

Title

arterial pressure monitoring

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morgan Le Guen

Organizational Affiliation

Hopital Foch

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc Fischler

Organizational Affiliation

Hopital Foch

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Foch

City

Suresnes

ZIP/Postal Code

92151

Country

France

12. IPD Sharing Statement

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

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