Status:

COMPLETED

Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

Lead Sponsor:

Hopital Lariboisière

Conditions:

Obesity

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Differen...

Eligibility Criteria

Inclusion

  • Patients aged between 18 and 60 years old.
  • Patients with morbid obesity (IMC \> 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
  • Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
  • Patient with a previous medical examination.
  • Patient giving its well-informed and free consent after information.

Exclusion

  • diabetes
  • concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
  • untreated sleep apnea syndrom, hypoxia (PaO2\<70mmHg) or hypercapnia (PaCO2\>45mmHg), anaemia \<10g/dL, ASAT or ALAT\>3N

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00943969

Start Date

April 1 2009

End Date

January 1 2010

Last Update

December 16 2015

Active Locations (1)

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1

Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital

Paris, France, 75475