BronchospasmNCT01488643
Observational Study on Obese Patients During General Anesthesia
An observational study of Bronchospasm and Surgery, run by Larissa University Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Bronchospasm, Surgery, Obesity
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALL PATIENTS FROM BOTH TEAMS WILL UNDERGO TO LAPAROSCOPIC SURGERIES
Who may be able to join
- AGE > 18 AND < 78 YEARS
- BMI < 35
Who cannot join
- MENTAL DISORDERS EMERGENCY SURGERIES
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Larissa University Hospital
Larissa, Thessaly, 41110
Polychronis Ieropoulos, MD, 0036970885256, ieropolos@gmail.com
Georgios Vretzakis, AProf, 0032413502952, gvretzakis@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchospasm, Surgery, Obesity
- Keywords
- Bronchospasm, Laparoscopic Gastrectomy, Obesity
- Medical subject headings
- Bronchial Spasm, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OBESITY PATIENTS | PATIENTS WITH BMI >35 | |
| CONTROL TEAM BMI <35 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 min
Secondary outcomes (1)
The impact of intraoperative bronchospasm on postoperative complications
Recording the vital signs, blood gases and postoperative pain scores for the first 24 postoperative hours
Measured: 1 day (24 postoperative hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ieropoulos Polychronis, Larissa University Hospital
- Investigators
- IEROPOULOS POLYCHRONIS, MD, Principal investigator, UNIVERSITY HOSPITAL OF LARISSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488643
- Sponsor's protocol ID
- 5/24-2-2011
- Status last verified
- Dec 2011
- First submitted
- 6 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchospasm During General Anesthesia in Obese Patients
- ClinicalTrials.gov ID
- NCT01488643
- Acronym / sponsor ID
- 5/24-2-2011
- Conditions
- Bronchospasm, Surgery, Obesity
- Keywords
- Bronchospasm, Laparoscopic Gastrectomy, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBESITY PATIENTS | – | –PATIENTS WITH BMI >35 |
| CONTROL TEAM BMI <35 | – | – |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL PATIENTS FROM BOTH TEAMS WILL UNDERGO TO LAPAROSCOPIC SURGERIES
Key inclusion criteria (2 listed)
- AGE > 18 AND < 78 YEARS
- BMI < 35
Key exclusion criteria (1 listed)
- MENTAL DISORDERS EMERGENCY SURGERIES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The impact of intraoperative bronchospasm on postoperative complications
Time frame: 1 day (24 postoperative hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IEROPOULOS POLYCHRONIS, MD principal investigator
UNIVERSITY HOSPITAL OF LARISSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchospasm and Surgery, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the presence of bronchospasm in obese and non obese patients (time frame: 90 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011; AzTrials last refreshed its copy on 4 Nov 2026.