Observational Study on Obese Patients During General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Larissa University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ieropoulos Polychronis, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01488643
First received: December 6, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition
Bronchospasm
Surgery
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bronchospasm During General Anesthesia in Obese Patients

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • The difference in the presence of bronchospasm in obese and non obese patients [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    Recording the Peak pressure, plateau pressure, lung compliance, arterial blood gases and mean arterial blood pressure


Secondary Outcome Measures:
  • The impact of intraoperative bronchospasm on postoperative complications [ Time Frame: 1 day (24 postoperative hours) ] [ Designated as safety issue: No ]
    Recording the vital signs, blood gases and postoperative pain scores for the first 24 postoperative hours


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
OBESITY PATIENTS
PATIENTS WITH BMI >35
CONTROL TEAM BMI <35

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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ALL PATIENTS FROM BOTH TEAMS WILL UNDERGO TO LAPAROSCOPIC SURGERIES

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • MENTAL DISORDERS EMERGENCY SURGERIES
  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: NCT01488643

Locations
Greece
Larissa University Hospital Recruiting
Larissa, Thessaly, Greece, 41110
Contact: Polychronis Ieropoulos, MD    0036970885256    ieropolos@gmail.com   
Contact: Georgios Vretzakis, AProf    0032413502952    gvretzakis@yahoo.com   
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         
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: IEROPOULOS POLYCHRONIS, MD UNIVERSITY HOSPITAL OF LARISSA
  More Information

No publications provided

Responsible Party: Ieropoulos Polychronis, MD, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01488643     History of Changes
Other Study ID Numbers: 5/24-2-2011
Study First Received: December 6, 2011
Last Updated: December 7, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Larissa University Hospital:
Bronchospasm
Laparoscopic Gastrectomy
Obesity

Additional relevant MeSH terms:
Bronchial Spasm
Obesity
Bronchial Diseases
Respiratory Tract Diseases
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 August 01, 2014