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Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

NCT ID: NCT01652131

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside.

Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly.

All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.

Detailed Description

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Conditions

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Obesity Obesity, Morbid

Keywords

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general anesthesia volume kinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Tetrastarch (130/0.4)

In obese patients candidates to laparoscopic gastrojejunal bypass an infusion of Tetrastarch (130/0.4)) of 15mL/kg (of corrected weight) will be initiated after protocoled induction of general anesthesia. Blood samples will be taken at time 0 (after induction of anesthesia and before initiating infusion) and then every 5 minutes for half an hour and then every 15 minutes up to 90 minutes. Blood samples will be processed in the Institution's laboratory. Urine will be measured at the end of the intervention. With these data kinetic parameters will be estimated for each patient.

Group Type OTHER

Tetrastarch (130/0.4)

Intervention Type OTHER

Interventions

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Tetrastarch (130/0.4)

Intervention Type OTHER

Other Intervention Names

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Voluven 6%

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of obesity (IMC \>35kg/m2) that will be treated with gastrojejunal laparoscopic bypass

Exclusion Criteria

* Renal failure KDOQI \>3
* Cardiac failure NYHA III-IV
* Sepsis
* Allergy to tetrastarch
* Allergy to any of the anesthetic medication that is to be used in the protocol previously established
* Patients in which vasoactive drugs are used
* Patients in which the blood samples are completed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Maria Victoria Hernandez Martinez

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel F Herrera Hernandez, MD MSc PhD

Role: STUDY_DIRECTOR

National Institute of Medical Sciences, Salvador Zubiran

Maria V Hernandez Martinez, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Medical Sciences, Salvador Zubiran

Locations

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National Institute of Medical Sciences, Salvador Zubiran

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Maria V Hernandez Martinez, M.D.

Role: CONTACT

Phone: 52 55 54 87 09 00

Email: [email protected]

Guillermo Dominguez Cherit, M.D.

Role: CONTACT

Phone: 52 55 54 87 09 00

Email: [email protected]

Other Identifiers

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REF.343

Identifier Type: -

Identifier Source: org_study_id