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TerminatedNCT01594021NICOM-MAPUpdated Oct 31, 2016

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

A Phase 4 interventional study of Gelatin 500 mL and Gelatin 50 mL in Anesthesia, sponsored by Hopital Foch. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-31.

Sponsored by Hopital Foch · Phase 4, Interventional, and Prevention

Why this study was terminated
Difficulty of realization of the study
Phase
Phase 4
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia

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Keywords

  • propofol
  • anesthesia, induction
  • hypotension
  • cardiac output
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 17 is below the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients undergoing elective surgery.

Exclusion criteria

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%.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    High pre-emptive volume loading

    Drug: Gelatin 500 mL

  • Active comparator
    Low pre-emptive volume loading

    Drug: Gelatin 50 mL

Interventions

  • DrugGelatin 500 mL

    intravenous administration

  • DrugGelatin 50 mL

    intravenous administration

06

What researchers measure

Primary outcomes

  1. Hypotension

    mean arterial pressure less than 70% of the baseline measurement

    Time frame: 30 minutes

Secondary outcomes

  1. hemodynamic effect of leg passive elevation test

    Time frame: 30 minutes

  2. hemodynamic effect of volume loading

    Time frame: 30 minutes

  3. heart rate monitoring

    Time frame: 30 minutes

  4. propofol dose when bispectral index is 50

    Time frame: 30 minutes

  5. propofol site effect concentration when bispectral index is 50

    Time frame: 30 minutes

  6. arterial pressure monitoring

    Time frame: 30 minutes

07

Study locations

1 site
  • Hopital Foch
    Suresnes, 92151, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01594021
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
May 8, 2012
Start date
Jul 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Oct 31, 2016

Study contacts

Morgan Le Guen
principal investigator · Hopital Foch
Marc Fischler
study director · Hopital Foch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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