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The role of exhaled nitric oxide in patients with chronic obstructive pulmonary disease undergoing abdominal surgery

The role of exhaled nitric oxide in patients with chronic obstructive pulmonary disease undergoing abdominal surgery: evaluation of postoperative complications

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000211460
Acronym
NOXIOUS (exhaled Nitric OXIde in patients with chronic Obstructive pulmonary disease Undergoing Surg
Enrollment
70
Registered
2016-02-16
Start date
2014-09-01
Completion date
2016-01-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic Obstructive Pulmonary Disease (COPD) has been associated with major perioperative morbidities or mortalities especially in surgical patients receiving general anesthesia. The severity of the COPD and the degree of bronchial hyperreactivity will determine the perioperative anesthetic risk, therefore they have to be assessed by a thorough preoperative evaluation in order to give the rationale on which to decide for the adequate anaesthetic techniques. Increased levels of exhaled nitric oxide (eNO) have been reported in patients with advanced chronic obstructive pulmonary disease (COPD). The present study investigates if the levels of exhaled NO in patients with COPD can predict the risk for complications after surgery under general anesthesia. Values of exhaled NO are evaluated in patients diagnosed with COPD scheduled for surgery under general anesthesia. COPD is evaluated using BODE Index score based on the Modified MRC Dyspnoea Scale, the BMI and the 6 MWD combined with the forced expiratory volume in one second (FEV1) parameter. All patients are closely observed for presenting respiratory complications postoperatively.

Interventions

Preoperative examination for patients scheduled for major abdominal surgeries with diagnosis of COPD for: - FEV1%pred (the predicted amount as a percentage of the forced expiratory lung volume in one second) using a spirometric test according to the standard procedure - the 6 minute walking distance test (6 MWD) - the Modified Medical Research Council Dyspnoea Scale (MMRC). - the body mass index (BMI) In additional to all above standard care examinations all patients will be examined for exhaled

Preoperative examination for patients scheduled for major abdominal surgeries with diagnosis of COPD for: - FEV1%pred (the predicted amount as a percentage of the forced expiratory lung volume in one second) using a spirometric test according to the standard procedure - the 6 minute walking distance test (6 MWD) - the Modified Medical Research Council Dyspnoea Scale (MMRC). - the body mass index (BMI) In additional to all above standard care examinations all patients will be examined for exhaled NO measurement using a portable NO analyzer. All the examinations will be performed from an experienced anesthetist, within 1 week prior to surgery. The approximate duration of preoperative examinations is 1 hour. All patients are administered premedication with diazepam 5mg orally in the evening and in the morning before surgery. The induction of anesthesia includes intravenous infusion of midazolam 2,5 mg, 0,1mg fentanyl, propofol 2-2,5 mg/kg and rocuronium 0,6 mg/kg. Perioperative monitoring includes ECG, blood pressure measurement, Central Venous Pressure measurement, pulse oximeter and capnograph. Postoperatively all complications are recordeded as laryngospasm, bronchospasm, cough, dyspnea and tachypnea as well as the need for corticosteroids or bronchodilators administration. The values of blood gases 1 and 3 hours postoperatively as well as 3 days after surgery are recorded.

Sponsors

Faculty of Medicine, University of Thessaly
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients scheduled for major abdominal surgeries that were evaluated from an experienced physician were enrolled for the study. The inclusion criteria are: - age 18-75 years - a diagnosis of COPD according to the American Thoracic Society (ATS) criteria in a stable condition and free from exacerbations in the preceding four weeks - ASA physical status II, III, IV - Smoking patients

Exclusion criteria

Patients with: - other organ failure - cancer - inability to cooperate - patients with a recent exacerbation (e.g. requiring hospitalization or oral corticosteroids) - patients with another or coexisting respiratory disorder (e.g. COPD and bronchiectasis)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026