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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2023-12-08

Brief Summary

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

This study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (Ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (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

Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

NCT02266797

Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

TERMINATED PHASE3

High Dose Steroids for Dysphagia

NCT03256149

Dysphagia Cervical Spine Disease

WITHDRAWN NA

Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline

NCT02416934

Dysphagia

COMPLETED NA

The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients

NCT06482632

Anterior Cervical Pain

NOT_YET_RECRUITING NA

Detailed Description

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

The purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia following anterior cervical discectomy and fusion (ACDF). The medications include Ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. Eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a ACDF for radiculopathy or myelopathy. Participants will be recruited for a prospective, randomized, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (NSAID), (2) IV NSAID(1-time dose of 30mg of IV Ketorolac at time of closure), and (3) IV steroid (1-time dose of 10mg of IV dexamethasone at the time of closure. The primary outcome measures are patient questionnaires which include the EAT-10 and Bazaz classification for dysphagia and VHI-10 for dysphonia. In addition, the Neck Disability Index (NDI) and Visual Analogue Pain Scale (VAS) will also be collected. Research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail.

Conditions

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

Dysphagia Dysphonia

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

25 patients into 3 separate arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Only patients will be masked from which cohort they were randomized into.

Study Groups

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

Control

no steroid or non steroidal anti-inflammatory

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control

Ketorolac

one time dose of 30mg of IV Ketorolac at time of closure

Group Type ACTIVE_COMPARATOR

Intravenous Ketorolac

Intervention Type DRUG

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

dexamethasone

one time dose of 10mg of IV dexamethasone at the time of closure

Group Type ACTIVE_COMPARATOR

Intravenous Dexamethasone

Intervention Type DRUG

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

Interventions

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

Intravenous Ketorolac

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

Intervention Type DRUG

Intravenous Dexamethasone

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

Intervention Type DRUG

Placebo

Control

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* 19 years of age and older
* Undergoing anterior cervical discectomy and fusion (ACDF) for radiculopathy or myelopathy
* No known allergies or sensitivities to steroid or non-steroidal medications

Exclusion Criteria

* Procedure is being done for revision, trauma, infection or tumor
* Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestinal bleeding...)
* Patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes