Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

Not Applicable

• Conditions: Obesity; Obesity, Morbid
• Interventions: Other: Tetrastarch (130/0.4)

• Registration Number: NCT01652131
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-18
• Last Update Posted: 2012-11-20
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tetrastarch (130/0.4)	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.

Primary Outcome Measures

Name	Time	Method
description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)	90 minutes after beginning of the infusion	different kinetic parameters will be used to asses the behavior of the colloid solution

Trial Locations

Locations (1)

National Institute of Medical Sciences, Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico