The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia

Not Applicable

Completed

• Conditions: Swallowing Function
• Interventions: Drug: placebo; Drug: steroid injection

• Registration Number: NCT04717713
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Few methods were available to determine which muscle groups are associated with PD in details in previous investigations. Local steroid administration has shown some effects on PD in a large number meta-analysis. In this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on ACDF patients by using high resolution impedance manometry in patients receiving ACDF.

Detailed Description

Postoperative dysphagia (PD) is the most common complication after anterior cervical discectomy and fusion (ACDF). However, few methods were available to determine which muscle groups are associated with PD in details in previous investigations. Local steroid administration has shown some effects on PD in a large number meta-analysis. In this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on ACDF patients, and the also apply the high resolution impedance manometry (HRIM) on patients receiving ACDF for better delineation of the swallowing function. Pressure-flow analysis (PFA), derives pharyngeal pressure flow variables obtained from HRIM were used to analyze the mechanisms of PD.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Study Start: 2021-02-09
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients undergoing elective anterior cervical spine surgery

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Exclusion Criteria

• patients receiving spine surgery not at the first time
• patients with head and neck cancer
• patients receiving other surgeries at head and neck region
• patients had previous swallowing difficulty history

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	patients receiving saline injection for comparator
steroid group	steroid injection	patients receiving steroid injection for preventing postoperative dysphagia

Primary Outcome Measures

Name	Time	Method
pharyngeal pressure	preoperative, postoperative 1 month	muscle power at pharyngeal region

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan