High Dose Steroids for Dysphagia (SHDD)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dysphagia; Cervical Spine Disease
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L4M1
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anterior cervical spine surgery
• Elective surgery

Exclusion Criteria:

• Takes steroids for any reason
• Pre-existing condition leading to dysphagia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total	Drug: Dexamethasone; Other Names: Decradron
Placebo Comparator: Placebo group; Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total	Drug: Placebo; Normal saline (IV placebo); Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice evaluation	Voice handicap index	First day post-operatively
Dysphagia evaluation: MBSimp	Modified Barium Swallow with the calculation fof the MBSimp score	First day post-operatively
Soft tissue edema	Pre-vertebral soft tissue edema on X Ray	First day post-operatively
Airway evaluation	Rhino-Pharyngo-Laryngoscopy	First day post-operatively
Dysphagia evaluation: Rosenbeck	Modified Barium Swallow with calculation of the Rosenbeck score	First day post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperreflexia	hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale	3 months post-operatively
Fusion rate	Cervical spine fusion at site of surgery seen on CT scan	6 months after surgery
Pain	Subjective neck pain using analog pain scale	3 months after surgery
Strenght	4 limbs strengh assessment on a 0 to 5 scale	3 months after surgery
Crude touch sensation	Presence or absence of hypoesthesia in the limbs	3 months after surgery
Surgical site infection	Presence or absence of superficial or deep surgical site infection	3 months after surgery

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2015
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Musculoskeletal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Bone Diseases; Esophageal Diseases; Deglutition Disorders; Spinal Diseases; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CE 14.247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No