Bronchospasm Associated With High Nitric Oxide

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00666510
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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

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

Resource links provided by NLM:


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

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

No publications provided

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

Keywords provided by University of Sao Paulo:
nitric oxide
bronchospasm
anesthesia
induced sputum
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 23, 2014