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Clinical Trials/NCT01594021
NCT01594021TerminatedPhase 4

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

Hopital Foch1 site in 1 country17 target enrollmentStarted: July 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
17
Locations
1
Primary Endpoint
Hypotension
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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%.

Arms & Interventions

High pre-emptive volume loading

Experimental

Intervention: Gelatin 500 mL (Drug)

Low pre-emptive volume loading

Active Comparator

Intervention: Gelatin 50 mL (Drug)

Outcomes

Primary Outcomes

Hypotension

Time Frame: 30 minutes

mean arterial pressure less than 70% of the baseline measurement

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Efficacy of Preemptive Volume Loading to... | Clinical Trial