Observational Study on Obese Patients During General Anesthesia

December 7, 2011 updated by: Ieropoulos Polychronis, Larissa University Hospital

Bronchospasm During General Anesthesia in Obese Patients

There is increased frequency of asthma in obese patients. This study is trying to find out if there is a difference in the presence of bronchospasm during anesthesia in obese and non obese patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Obese patients come for surgery every day. In this specific population the frequency of asthma is high.

Problems from the respiratory system increase the morbidity, as they are a significant part of perioperative complications.

The frequency and the severity of bronchospasm have not been studied. Any data concerning the bronchospasm will lead to better perioperative management.

In this study the investigators study any sign of bronchospasm during surgery in obese patients.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Recruiting
        • Larissa University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Polychronis Ieropoulos, MD
        • Sub-Investigator:
          • Georgios Vretzakis, PhD
        • Sub-Investigator:
          • Flossos Andreas, MD
        • Sub-Investigator:
          • Vasilios Tasoudis, MD
        • Sub-Investigator:
          • Petsiti Argyro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALL PATIENTS FROM BOTH TEAMS WILL UNDERGO TO LAPAROSCOPIC SURGERIES

Description

Inclusion Criteria:

  • AGE > 18 AND < 78 YEARS
  • BMI < 35

Exclusion Criteria:

  • MENTAL DISORDERS EMERGENCY SURGERIES

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OBESITY PATIENTS
PATIENTS WITH BMI >35
CONTROL TEAM BMI <35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in the presence of bronchospasm in obese and non obese patients
Time Frame: 90 min
Recording the Peak pressure, plateau pressure, lung compliance, arterial blood gases and mean arterial blood pressure
90 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of intraoperative bronchospasm on postoperative complications
Time Frame: 1 day (24 postoperative hours)
Recording the vital signs, blood gases and postoperative pain scores for the first 24 postoperative hours
1 day (24 postoperative hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Investigators

  • Principal Investigator: IEROPOULOS POLYCHRONIS, MD, University Hospital of Larissa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/24-2-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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