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

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Gelatin 500 mL; Drug: Gelatin 50 mL

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High pre-emptive volume loading	Drug: Gelatin 500 mL; intravenous administration
Active Comparator: Low pre-emptive volume loading	Drug: Gelatin 50 mL; intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	mean arterial pressure less than 70% of the baseline measurement	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
hemodynamic effect of leg passive elevation test	30 minutes
hemodynamic effect of volume loading	30 minutes
heart rate monitoring	30 minutes
propofol dose when bispectral index is 50	30 minutes
propofol site effect concentration when bispectral index is 50	30 minutes
arterial pressure monitoring	30 minutes

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Morgan Le Guen, Hopital Foch; Study Director: Marc Fischler, Hopital Foch

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 5, 2012
• First Submitted That Met QC Criteria: May 5, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: propofol; hypotension; cardiac output; anesthesia, induction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2012/13; 2012-A00368-35 (Other Identifier: ANSM)