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

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.
ClinicalTrials.gov Identifier: NCT01703897
Recruitment Status : Withdrawn
First Posted : October 11, 2012
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Condition or disease Intervention/treatment
Obesity 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.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Obese patients Device: Manometry and Impedance analysis

Outcome Measures

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

Eligibility Criteria

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

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

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 Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

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