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

National Taiwan University

Status: Completed

Conditions: Swallowing Function

Treatments: Drug: steroid injection; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04717713

202002052MIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective anterior cervical spine surgery

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

steroid group

Experimental group

Description:

patients receiving steroid injection for preventing postoperative dysphagia

Treatment:

Drug: steroid injection

placebo group

Placebo Comparator group

Description:

patients receiving saline injection for comparator

Treatment:

Drug: placebo