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Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703897
First Posted: October 11, 2012
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alex de Leon, Örebro University, Sweden
  Purpose
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Condition Intervention
Obesity Device: Manometry and Impedance analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry

Resource links provided by NLM:


Further study details as provided by Alex de Leon, Örebro University, Sweden:

Primary Outcome Measures:
  • Esophageal pressures after laparoscopic gastric by pass [ Time Frame: 2 years after surgery ]

Enrollment: 0
Study Start Date: October 2012
Groups/Cohorts Assigned Interventions
Obese patients Device: Manometry and Impedance analysis

Detailed Description:

Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia.

Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI > 35, undergoing laparoscopic gastric by-pass.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obese patients
Criteria

Inclusion Criteria:

  • Male and female patients
  • aged 18-60 years
  • BMI>35
  • ASA classification I-III

Exclusion Criteria:

  • Use of drugs that interfere with esophageal motility
  • Gastro-esophageal reflux disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703897


Locations
Sweden
Department of Anesthesiology and Intensive care, University Hospital of Örebro
Örebro, Sweden, 70162
Sponsors and Collaborators
Örebro University, Sweden
  More Information

Responsible Party: Alex de Leon, MD, PhD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01703897     History of Changes
Other Study ID Numbers: Linde-Imped
First Submitted: October 8, 2012
First Posted: October 11, 2012
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Alex de Leon, Örebro University, Sweden:
gastric by-pass surgery