drugset / Trial / NCT01065961

Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis

NCT01065961 ↗

Phase 1/2 Unknown 200 enrolled Albany Medical College
RandomizedParallel-groupDouble-blindTreatment

Summary

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma. The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

Timeline

Start
2008-11
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 4 mg —

Indications

No indication recorded.