Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia
This study is currently recruiting participants.
Verified November 2012 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor:
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Information provided by (Responsible Party):
Maria Victoria Hernandez Martinez, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01652131
First received: July 25, 2012
Last updated: November 18, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Obesity, Morbid |
Other: Tetrastarch (130/0.4) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia |
Resource links provided by NLM:
Further study details as provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
Primary Outcome Measures:
- description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4) [ Time Frame: 90 minutes after beginning of the infusion ] [ Designated as safety issue: No ]different kinetic parameters will be used to asses the behavior of the colloid solution
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: Tetrastarch (130/0.4)
Other Name: Voluven 6%
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652131
Contacts
| Contact: Maria V Hernandez Martinez, M.D. | 52 55 54 87 09 00 ext 5020/5021 | mvictoria20@me.com |
| Contact: Guillermo Dominguez Cherit, M.D. | 52 55 54 87 09 00 ext 5020/5021 | guidom@prodigy.net.mx |
Locations
| Mexico | |
| National Institute of Medical Sciences, Salvador Zubiran | Recruiting |
| Mexico City, Distrito Federal, Mexico, 14000 | |
| Sub-Investigator: Bernardo Gutierrez Sougarret, M.D. | |
| Sub-Investigator: Guillermo Dominguez Cherit, M.D. | |
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Investigators
| Study Director: | Miguel F Herrera Hernandez, MD MSc PhD | National Institute of Medical Sciences, Salvador Zubiran |
| Principal Investigator: | Maria V Hernandez Martinez, M.D. | National Institute of Medical Sciences, Salvador Zubiran |
More Information
No publications provided
| Responsible Party: | Maria Victoria Hernandez Martinez, M.D., National Institute of Medical Sciences and Nutrition, Salvador Zubiran |
| ClinicalTrials.gov Identifier: | NCT01652131 History of Changes |
| Other Study ID Numbers: | REF.343 |
| Study First Received: | July 25, 2012 |
| Last Updated: | November 18, 2012 |
| Health Authority: | Mexico: Secretaria de Salud |
Keywords provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
|
general anesthesia volume kinetics |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013