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NCT05136781 Clinical Trial

DEXAMETHASONE for Non-urgent Thoracic Surgery

Thoracic Surgery Clinical Trial

— SURTHODEX  

Official title:
Assessment of DEXAMETHASONE to Prevent Respiratory Complications After Non Urgent Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05136781
Other study ID # PI2021_843_0202
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2021
Est. completion date March 2024

Study information
Verified date April 2023
Source Centre Hospitalier Universitaire, Amiens
Contact YOHAN GERMAIN, MD
Phone 0322037347
Email yohan.germain@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thoracic surgery is at high risk of respiratory complications. Despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. Thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. Similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. In addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery. Since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. By retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications

Recruitment information / eligibility
Status Recruiting
Enrollment 1600
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age : minimum 18 years old - Patients who underwent scheduled lung resection surgery Exclusion Criteria: - absence of patient's consent - age under 18 years - pregnant women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Universitaire d'Amiens Amiens Picardie

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of respiratory failure rates between patients receiving or not DEXAMETHASONE 7 days following surgery
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