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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2022-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Local Intraoperative Steroid on Dysphagia After ACDF

NCT03311425

Dysphagia

COMPLETED PHASE3

High Dose Steroids for Dysphagia

NCT03256149

Dysphagia Cervical Spine Disease

WITHDRAWN NA

The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF

NCT04650893

Dysphagia Dysphonia

TERMINATED PHASE3

Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

NCT02724761

Dysphagia Dysphonia Postoperative Pain

UNKNOWN NA

Enhancing Early Swallowing Recovery in Older Dysphagic Patients Afetr Anterior Cervical Spine Surgery

NCT05494515

Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Swallowing Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

steroid group

patients receiving steroid injection for preventing postoperative dysphagia

Group Type EXPERIMENTAL

steroid injection

Intervention Type DRUG

steroid injection at surgical location

placebo group

patients receiving saline injection for comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

saline injection at surgical location

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

steroid injection

steroid injection at surgical location

Intervention Type DRUG

placebo

saline injection at surgical location

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No