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

Anesthesia Clinical Trial

— NICOM-MAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01594021
• Other study ID #: 2012/13
• Secondary ID: 2012-A00368-35
• Status: Terminated
• Phase: Phase 4
• First received: May 5, 2012
• Last updated: October 28, 2016
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Hypotension

Intervention

Drug:
• Gelatin 500 mL
intravenous administration
• Gelatin 50 mL
intravenous administration

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	mean arterial pressure less than 70% of the baseline measurement	30 minutes	Yes
Secondary	hemodynamic effect of leg passive elevation test		30 minutes	No
Secondary	hemodynamic effect of volume loading		30 minutes	No
Secondary	heart rate monitoring		30 minutes	No
Secondary	propofol dose when bispectral index is 50		30 minutes	No
Secondary	propofol site effect concentration when bispectral index is 50		30 minutes	No
Secondary	arterial pressure monitoring		30 minutes	No