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

Swallowing Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717713
• Other study ID #: 202002052MIND
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Function

Intervention

Drug:
• steroid injection
steroid injection at surgical location
• placebo
saline injection at surgical location

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharyngeal pressure	muscle power at pharyngeal region	preoperative, postoperative 1 month