Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

NCT02266797 | Terminated Phase 3 Results

• 1 other identifier: 13-00108
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (4)

• The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.

  12 months

• Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.

  Immediate post-operatively

• Examine the Impact of Dexamethasone on Radicular Pain.

  12 months

• Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.

  12 months

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Saline

PLACEBO COMPARATOR

Subject will receive doses of intravenous physiological saline solution.

Other: Saline

Interventions

Dexamethasone DRUG

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.

Dexamethasone

Saline OTHER

The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.

Saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

Center for Musculoskeletal Care (CMC)

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

NY Spine Institute

Westbury, New York, 11590, United States

Location

Related Publications (5)

• 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.

  PMID: 21325988 BACKGROUND

• 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.

  PMID: 12435974 BACKGROUND

• 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.

  PMID: 8561932 BACKGROUND

• 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.

  PMID: 11177014 BACKGROUND

• 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.

  PMID: 8997826 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Michael Gerling
• Organization: NYU Langone Medical Center

Michael.Gerling@nyumc.org

(718) 630-8600

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 17, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 25, 2018
• Results First Posted: March 14, 2016

Record last verified: 2018-09

Locations

US (3)