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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594021
Recruitment Status : Terminated (Difficulty of realization of the study)
First Posted : May 8, 2012
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Gelatin 500 mL Drug: Gelatin 50 mL Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

Arm Intervention/treatment
Experimental: High pre-emptive volume loading Drug: Gelatin 500 mL
intravenous administration

Active Comparator: Low pre-emptive volume loading Drug: Gelatin 50 mL
intravenous administration




Primary Outcome Measures :
  1. Hypotension [ Time Frame: 30 minutes ]
    mean arterial pressure less than 70% of the baseline measurement


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594021


Locations
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France
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Morgan Le Guen Hopital Foch
Study Director: Marc Fischler Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01594021    
Other Study ID Numbers: 2012/13
2012-A00368-35 ( Other Identifier: ANSM )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by Hopital Foch:
propofol
anesthesia, induction
hypotension
cardiac output
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases