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

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Anesthesia

Treatments: Drug: Gelatin 50 mL; Drug: Gelatin 500 mL

Study type: Interventional

Funder types: Other

Identifiers

NCT01594021

2012/13

2012-A00368-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

High pre-emptive volume loading

Experimental group

Treatment:

Drug: Gelatin 500 mL

Low pre-emptive volume loading

Active Comparator group

Treatment:

Drug: Gelatin 50 mL