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

This study has been terminated.
(Difficulty of realization of the study)
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01594021
First received: May 5, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Anesthesia
Drug: Gelatin 500 mL
Drug: Gelatin 50 mL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Hypotension [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    mean arterial pressure less than 70% of the baseline measurement


Secondary Outcome Measures:
  • hemodynamic effect of leg passive elevation test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • hemodynamic effect of volume loading [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • heart rate monitoring [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • propofol dose when bispectral index is 50 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • propofol site effect concentration when bispectral index is 50 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • arterial pressure monitoring [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594021

Locations
France
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen Hopital Foch
Study Director: Marc Fischler Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01594021     History of Changes
Other Study ID Numbers: 2012/13
Study First Received: May 5, 2012
Last Updated: October 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
propofol
anesthesia, induction
hypotension
cardiac output

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014