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

• Sponsor: Örebro University, Sweden (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01703897
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

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	Phase
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: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Obese patients	Device: Manometry and Impedance analysis

Outcome Measures

Primary Outcome Measures

1. Esophageal pressures after laparoscopic gastric by pass [2 years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Intensive care, University Hospital of Örebro	Örebro		Sweden	70162

Sponsors and Collaborators

• Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alex de Leon, MD, PhD, Örebro University, Sweden
• ClinicalTrials.gov Identifier: NCT01703897
• Other Study ID Numbers: Linde-Imped
• First Posted: Oct 11, 2012
• Last Update Posted: Nov 5, 2014
• Last Verified: Nov 1, 2014

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

Study Results

No Results Posted as of Nov 5, 2014