跳至主要内容
临床试验/NCT04650893
NCT04650893终止3 期

The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion

University of Nebraska1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
33
试验地点
1
主要终点
Percentage of Patients With Moderate/Severe Bazaz Classification

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control

Placebo Comparator

no steroid or non steroidal anti-inflammatory

干预措施: Placebo (Drug)

Ketorolac

Active Comparator

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

干预措施: Intravenous Ketorolac (Drug)

dexamethasone

Active Comparator

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

干预措施: Intravenous Dexamethasone (Drug)

结局指标

主要结局

Percentage of Patients With Moderate/Severe Bazaz Classification

时间窗: one year

The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation

Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)

时间窗: one year

Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10).Scores on the EAT-10 greater than 15 are indicative of severe dysphonia.

次要结局

  • Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).(one year)
  • Mean Neck Disability Index (NDI)(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验