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Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

N

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Status

Unknown

Conditions

Obesity
Obesity, Morbid

Treatments

Other: Tetrastarch (130/0.4)

Study type

Interventional

Funder types

Other

Identifiers

NCT01652131
REF.343

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Tetrastarch (130/0.4)
Other group
Description:
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.
Treatment:
Other: Tetrastarch (130/0.4)

Trial contacts and locations

1

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Central trial contact

Guillermo Dominguez Cherit, M.D.; Maria V Hernandez Martinez, M.D.

Data sourced from clinicaltrials.gov

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