Observational Study on Obese Patients During General Anesthesia

Obesity Clinical Trial

Official title:

Bronchospasm During General Anesthesia in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01488643
• Other study ID #: 5/24-2-2011
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2011
• Last updated: December 7, 2011
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2011
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• AGE > 18 AND < 78 YEARS

• BMI < 35

Exclusion Criteria:

• MENTAL DISORDERS EMERGENCY SURGERIES

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchial Spasm
• Bronchospasm
• Obesity
• Surgery

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the presence of bronchospasm in obese and non obese patients	Recording the Peak pressure, plateau pressure, lung compliance, arterial blood gases and mean arterial blood pressure	90 min	No
Secondary	The impact of intraoperative bronchospasm on postoperative complications	Recording the vital signs, blood gases and postoperative pain scores for the first 24 postoperative hours	1 day (24 postoperative hours)	No