High Dose Steroids for Dysphagia

Dysphagia Clinical Trial

— SHDD  

Official title:

Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03256149
• Other study ID #: CE 14.247
• Status: Withdrawn
• Phase: N/A
• Start date: March 24, 2015
• Est. completion date: February 2019

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anterior cervical spine surgery

• Elective surgery

Exclusion Criteria:

• Takes steroids for any reason

• Pre-existing condition leading to dysphagia

Related Conditions & MeSH terms

• Cervical Spine Disease
• Deglutition Disorders
• Dysphagia
• Spinal Diseases

Intervention

Drug:
• Dexamethasone

• Placebo
Normal saline (IV placebo)

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice evaluation	Voice handicap index	First day post-operatively
Primary	Dysphagia evaluation: MBSimp	Modified Barium Swallow with the calculation fof the MBSimp score	First day post-operatively
Primary	Soft tissue edema	Pre-vertebral soft tissue edema on X Ray	First day post-operatively
Primary	Airway evaluation	Rhino-Pharyngo-Laryngoscopy	First day post-operatively
Primary	Dysphagia evaluation: Rosenbeck	Modified Barium Swallow with calculation of the Rosenbeck score	First day post-operatively
Secondary	Hyperreflexia	hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale	3 months post-operatively
Secondary	Fusion rate	Cervical spine fusion at site of surgery seen on CT scan	6 months after surgery
Secondary	Pain	Subjective neck pain using analog pain scale	3 months after surgery
Secondary	Strenght	4 limbs strengh assessment on a 0 to 5 scale	3 months after surgery
Secondary	Crude touch sensation	Presence or absence of hypoesthesia in the limbs	3 months after surgery
Secondary	Surgical site infection	Presence or absence of superficial or deep surgical site infection	3 months after surgery