Phase 4
Completed N=190
Ipratropium Bromide in Peri-Operative COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01943552 ↗
Enrolled (actual)
190
Serious AEs
4.7%
Results posted
Sep 2016
Primary outcomePrimary: Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery — 169.9; 15.0 ml — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese peri-operative patients with COPD under general anaesthesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery |
169.9; 15.0 | <0.0001 sig |
| SECONDARY Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery |
59.4; 8.5 | 0.3509 |
| SECONDARY Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value |
3.2; 0.5 | 0.2069 |
| SECONDARY Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation |
0.6; 0.3 | 0.1899 |
| SECONDARY Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value |
-0.1; -0.5 | 0.4758 |
| SECONDARY Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery |
8; 14 | 0.1779 |
Eligibility Criteria
Inclusion criteria
- All patients must sign an informed consent.
- Male or female patients aged >= 40 years and = 600 / mm3 (0.6×10^9/L). A repeat eosinophil count will not be conducted in these patients
Data sourced from ClinicalTrials.gov (NCT01943552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.