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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594021

Acronym

NICOM-MAP

Enrollment

Registered

2012-05-08

Start date

2012-07-31

Completion date

2014-06-30

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

propofol, anesthesia, induction, hypotension, cardiac output

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.

Interventions

DRUGGelatin 500 mL

intravenous administration

DRUGGelatin 50 mL

intravenous administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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%.

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026