High Dose Steroids for Dysphagia (SHDD)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Withdrawn

Conditions: Dysphagia; Cervical Spine Disease

Treatments: Drug: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03256149

CE 14.247

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anterior cervical spine surgery
• Elective surgery

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo