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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Örebro University, Sweden
Sponsor:
Information provided by (Responsible Party):
Alex de Leon, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01703897
First received: October 8, 2012
Last updated: October 10, 2012
Last verified: October 2012
  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 Örebro University, Sweden:

Estimated Enrollment: 16
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703897

Locations
Sweden
Örebro University Hospital Recruiting
Örebro, Sweden, 70352
Contact: Alex de Leon, MD, PhD    +46196021111    alex.deleon@orebroll.se   
Principal Investigator: Per Cajandeer, MD         
Sponsors and Collaborators
Örebro University, Sweden
  More Information

No publications provided

Responsible Party: Alex de Leon, MD, PhD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01703897     History of Changes
Other Study ID Numbers: Linde-Imped
Study First Received: October 8, 2012
Last Updated: October 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Obesity
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 July 22, 2014