Observational Study on Obese Patients During General Anesthesia
This study is currently recruiting participants.
Verified December 2011 by Larissa University Hospital
Sponsor:
Larissa University Hospital
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
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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
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 June 18, 2013