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High Dose Steroids for Dysphagia (SHDD)

Primary Purpose

Dysphagia, Cervical Spine Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anterior cervical spine surgery
  • Elective surgery

Exclusion Criteria:

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Voice evaluation
Voice handicap index
Dysphagia evaluation: MBSimp
Modified Barium Swallow with the calculation fof the MBSimp score
Soft tissue edema
Pre-vertebral soft tissue edema on X Ray
Airway evaluation
Rhino-Pharyngo-Laryngoscopy
Dysphagia evaluation: Rosenbeck
Modified Barium Swallow with calculation of the Rosenbeck score

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2017
Last Updated
December 12, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03256149
Brief Title
High Dose Steroids for Dysphagia
Acronym
SHDD
Official Title
Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough patients recruted
Study Start Date
March 24, 2015 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Cervical Spine Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decradron
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Normal saline (IV placebo)
Primary Outcome Measure Information:
Title
Voice evaluation
Description
Voice handicap index
Time Frame
First day post-operatively
Title
Dysphagia evaluation: MBSimp
Description
Modified Barium Swallow with the calculation fof the MBSimp score
Time Frame
First day post-operatively
Title
Soft tissue edema
Description
Pre-vertebral soft tissue edema on X Ray
Time Frame
First day post-operatively
Title
Airway evaluation
Description
Rhino-Pharyngo-Laryngoscopy
Time Frame
First day post-operatively
Title
Dysphagia evaluation: Rosenbeck
Description
Modified Barium Swallow with calculation of the Rosenbeck score
Time Frame
First day post-operatively
Secondary Outcome Measure Information:
Title
Hyperreflexia
Description
hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale
Time Frame
3 months post-operatively
Title
Fusion rate
Description
Cervical spine fusion at site of surgery seen on CT scan
Time Frame
6 months after surgery
Title
Pain
Description
Subjective neck pain using analog pain scale
Time Frame
3 months after surgery
Title
Strenght
Description
4 limbs strengh assessment on a 0 to 5 scale
Time Frame
3 months after surgery
Title
Crude touch sensation
Description
Presence or absence of hypoesthesia in the limbs
Time Frame
3 months after surgery
Title
Surgical site infection
Description
Presence or absence of superficial or deep surgical site infection
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anterior cervical spine surgery Elective surgery Exclusion Criteria: Takes steroids for any reason Pre-existing condition leading to dysphagia
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High Dose Steroids for Dysphagia

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