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

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01594021
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jul 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hypotension [30 minutes]

   mean arterial pressure less than 70% of the baseline measurement

Secondary Outcome Measures

1. hemodynamic effect of leg passive elevation test [30 minutes]

2. hemodynamic effect of volume loading [30 minutes]

3. heart rate monitoring [30 minutes]

4. propofol dose when bispectral index is 50 [30 minutes]

5. propofol site effect concentration when bispectral index is 50 [30 minutes]

6. arterial pressure monitoring [30 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes		France	92151

Sponsors and Collaborators

• Hopital Foch

Investigators

• Principal Investigator: Morgan Le Guen, Hopital Foch
• Study Director: Marc Fischler, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01594021
• Other Study ID Numbers: 2012/13; 2012-A00368-35
• First Posted: May 8, 2012
• Last Update Posted: Oct 31, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Hopital Foch: propofol; anesthesia, induction; hypotension; cardiac output
• Additional relevant MeSH terms: Hypotension

Study Results

No Results Posted as of Oct 31, 2016