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

The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia - A Prospective Double-Blinded Study by High Resolution Impedance Manometry

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04717713

Enrollment

Registered

2021-01-22

Start date

2021-02-09

Completion date

2022-09-20

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing Function

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.

Interventions

DRUGsteroid injection

steroid injection at surgical location

DRUGplacebo

saline injection at surgical location

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
pharyngeal pressure	preoperative, postoperative 1 month	muscle power at pharyngeal region

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026