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NCT01703897 Clinical Trial

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

Obesity Clinical Trial

Official title:
Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01703897
Other study ID # Linde-Imped
Secondary ID
Status Withdrawn
Phase N/A
First received October 8, 2012
Last updated November 4, 2014
Start date October 2012

Study information
Verified date November 2014
Source Örebro University, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Manometry and Impedance analysis

Locations
Country Name City State
Sweden Department of Anesthesiology and Intensive care, University Hospital of Örebro Örebro

Sponsors (1)
Lead Sponsor Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Esophageal pressures after laparoscopic gastric by pass 2 years after surgery No
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