High Dose Steroids for Dysphagia

NCT03256149 | Withdrawn DMC

• 1 other identifier: CE 14.247
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Cervical Spine Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Hyperreflexia

  3 months post-operatively

• Fusion rate

  6 months after surgery

• Pain

  3 months after surgery

• Strenght

  3 months after surgery

• Crude touch sensation

  3 months after surgery

Study Arms (2)

Treatment group

EXPERIMENTAL

Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total

Drug: Dexamethasone

Placebo group

PLACEBO COMPARATOR

Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total

Drug: Placebo

Interventions

Dexamethasone DRUG

Also known as: Decradron

Treatment group

Placebo DRUG

Normal saline (IV placebo)

Also known as: Saline

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior cervical spine surgery
• Elective surgery

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L4M1, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: March 24, 2015
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

CA (1)