Overview

This trial is active, not recruiting.

Condition dysphagia
Treatments treatment 1; dexamethasone, treatment 0; saline placebo
Sponsor West Virginia University
Start date July 2012
End date May 2016
Trial size 74 participants
Trial identifier NCT02416934, 1405296745

Summary

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.
treatment 1; dexamethasone Steroid
Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
(Placebo Comparator)
Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.
treatment 0; saline placebo Saline
Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.

Primary Outcomes

Measure
Change in Severity of swallowing difficulty
time frame: Baseline; Day 1; Day 2; Wk 1; Wk 2; 1 month; 3 month; 6 months;12 months

Secondary Outcomes

Measure
Change in Pain
time frame: Baseline; 12 months
Change in Quality of life
time frame: Baseline; 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Elective anterior approach to subaxial cervical spine (C3 - T1); - ages 18-80 Exclusion Criteria: - Traumatic or tumor etiologies - undergoing anterior-posterior operations - neoplastic, or infectious conditions requiring surgery - a history of previous anterior cervical spine surgery - any patient requiring a halo vest - patients on chronic steroids - patients remaining intubated post-operatively (please see more under risks below) - less than 18 years of age - pregnant women - no phone

Additional Information

Official title The Effects of Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study.
Principal investigator Sanford E Emery, MD, MBA
Description This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz scale and the Dysphagia Short Questionnaire. Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Other data to be collected for analysis includes patient comorbidities, levels and type of surgery, intra-operative fluids, estimated blood loss, type of retractors, type of brace if any, length of stay, and other surgically related complications. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the QoL-12, Neck Disability Index, and Visual Analog Scale questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by West Virginia University.