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High Dose Steroids for Dysphagia

NCT ID: NCT03256149

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-24

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Cervical Spine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline (IV placebo)

Interventions

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Dexamethasone

Intervention Type DRUG

Placebo

Normal saline (IV placebo)

Intervention Type DRUG

Other Intervention Names

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Decradron Saline

Eligibility Criteria

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Inclusion Criteria

* Anterior cervical spine surgery
* Elective surgery

Exclusion Criteria

* Takes steroids for any reason
* Pre-existing condition leading to dysphagia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CE 14.247

Identifier Type: -

Identifier Source: org_study_id