High Dose Steroids for Dysphagia

Not Applicable

Withdrawn

• Conditions: Cervical Spine Disease; Dysphagia
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT03256149
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-24
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Primary Completion: 2018-11
• Study Completion: 2019-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Anterior cervical spine surgery
• Elective surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Dexamethasone	Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Placebo group	Placebo	Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada