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

Phase 4

Terminated

• Conditions: Anesthesia
• Interventions: Drug: Gelatin 50 mL; Drug: Gelatin 500 mL

• Registration Number: NCT01594021
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-05
• Study First Posted: 2012-05-08
• Study Start: 2012-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Adult patients undergoing elective surgery.

Read More

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%.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low pre-emptive volume loading	Gelatin 50 mL	-
High pre-emptive volume loading	Gelatin 500 mL	-

Primary Outcome Measures

Name	Time	Method
Hypotension	30 minutes	mean arterial pressure less than 70% of the baseline measurement

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France