Bronchospasm Associated With High Nitric Oxide - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00666510

Purpose

Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.

Condition
Asthma Airway Hyperresponsiveness

MedlinePlus related topics: Anesthesia Asthma

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Retrospective
Official Title:	Higher Exhaled Nitric Oxide (NO) is Associated With Intraoperative Bronchospasm

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Exhaled nitric oxide in parts per billion [ Time Frame: one to six months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Eosinophils concentration within sputum sample, pulmonary function tests [ Time Frame: one to six months after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Sputum

Enrollment:	31
Study Start Date:	January 1999
Study Completion Date:	December 2004

Groups/Cohorts
Bronchospasm Patients who presented bronchospasm during anesthesia induction
Asthma Patients who presented bronchospasm during anesthesia induction and were identified as asthmatics
Control Patients who were submitted to anesthesia induction and showed no complications

Detailed Description:

Previous studies in asthmatic patients suggested that exhaled nitric oxide may represent a noninvasive measure for airway inflammation. Anesthesia information forms from 1999 throughout 2004 were revised (n=146.358). Bronchospasm occurrence appeared registered on 863 forms. From those, nine were identified as non-asthmatics patients (Bronchospasm group). Also, 12 asthmatics constituted one additional group (Asthma group) and 10 subjects with no previous airway disease or symptoms (Control group). All subjects were submitted to Exhaled nitric oxide measurements (parts/billion), spirometry and induced sputum.

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Hospital, late post-anesthesia cared patients

Criteria

Inclusion Criteria:

patients with no systemic disease and registered bronchospasm during anesthesia induction

Exclusion Criteria:

hypertension, COPD, diabetes, pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666510

Locations

Brazil
Hospital das Clínicas da FMUSP
São Paulo, Brazil, 05430 010

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Joaquim E Vieira, MD, PhD

University of Sao Paulo Medical School - FMUSP

More Information

Responsible Party:	Fisiopatologia Experimental FMUSP ( Joaquim Edson Vieira )
Study ID Numbers:	CAP125-01
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666510
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

nitric oxide
bronchospasm
anesthesia
induced sputum
asthma

Study placed in the following topic categories:

Nitric Oxide
Spasm
Hypersensitivity
Lung Diseases, Obstructive
Bronchial Spasm

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Bronchial Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009