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

Primary Purpose

Swallowing Function

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
steroid injection
placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Swallowing Function

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

steroid group

placebo group

Arm Description

patients receiving steroid injection for preventing postoperative dysphagia

patients receiving saline injection for comparator

Outcomes

Primary Outcome Measures

pharyngeal pressure
muscle power at pharyngeal region

Secondary Outcome Measures

Full Information

First Posted
January 18, 2021
Last Updated
July 30, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04717713
Brief Title
The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia
Official Title
The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia - A Prospective Double-Blinded Study by High Resolution Impedance Manometry
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
steroid group
Arm Type
Experimental
Arm Description
patients receiving steroid injection for preventing postoperative dysphagia
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
patients receiving saline injection for comparator
Intervention Type
Drug
Intervention Name(s)
steroid injection
Intervention Description
steroid injection at surgical location
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
saline injection at surgical location
Primary Outcome Measure Information:
Title
pharyngeal pressure
Description
muscle power at pharyngeal region
Time Frame
preoperative, postoperative 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
225
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
due to ethic concern

Learn more about this trial

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

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