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Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

Primary Purpose

Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subjects included in the study are patients undergoing an anterior cervical spine procedure.

Exclusion Criteria:

  • Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.

Sites / Locations

  • Center for Musculoskeletal Care (CMC)
  • NYU Langone Medical Center
  • NY Spine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Saline

Arm Description

Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.

Subject will receive doses of intravenous physiological saline solution.

Outcomes

Primary Outcome Measures

Intravenous Corticosteroids Effect on Post-operative Dysphagia
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.

Secondary Outcome Measures

The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Examine the Impact of Dexamethasone on Radicular Pain.
This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
The outcomes of surgery will be examined through the 1 year post-operative appointment.

Full Information

First Posted
October 2, 2014
Last Updated
September 26, 2018
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02266797
Brief Title
Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
Official Title
Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
Detailed Description
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Subject will receive doses of intravenous physiological saline solution.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
Primary Outcome Measure Information:
Title
Intravenous Corticosteroids Effect on Post-operative Dysphagia
Description
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
Time Frame
12 months
Title
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Description
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
Description
Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.
Time Frame
12 months
Title
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
Description
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Time Frame
Immediate post-operatively
Title
Examine the Impact of Dexamethasone on Radicular Pain.
Description
This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Time Frame
12 months
Title
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
Description
The outcomes of surgery will be examined through the 1 year post-operative appointment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects included in the study are patients undergoing an anterior cervical spine procedure. Exclusion Criteria: Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
Facility Information:
Facility Name
Center for Musculoskeletal Care (CMC)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NY Spine Institute
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21325988
Citation
Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7.
Results Reference
background
PubMed Identifier
12435974
Citation
Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
Results Reference
background
PubMed Identifier
8561932
Citation
Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. doi: 10.1080/02688699550040882.
Results Reference
background
PubMed Identifier
11177014
Citation
Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. doi: 10.1001/archotol.127.1.51.
Results Reference
background
PubMed Identifier
8997826
Citation
Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. doi: 10.1007/pl00009513.
Results Reference
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Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

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