Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery

Phase 1

Withdrawn

• Conditions: Dysphagia
• Interventions: Drug: 3% Sodium Chloride; Drug: Normal Saline

• Registration Number: NCT03677310
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.

Detailed Description

Based on a priori analysis the investigators will need 100 subjects in a placebo arm (normal saline) and 100 subjects in a treatment arm (3% sodium chloride), for a total of 200 patients. This study will be conducted on healthy subjects with normal renal function undergoing anterior cervical discectomy and fusion for degenerative indications only. Subjects will be randomized to the treatment or placebo arm (which will be double blinded). Subjects in the treatment arm will begin to receive intravenous 3% sodium chloride before the incision is made. The solution will be given at a rate of 10 cc/hour over a period of 24 hours. Baseline, post-operative, and delayed post-operative dysphagia surveys will be administered either in person or by telephone. The investigators hope to decrease the incidence and severity of post-operative dysphagia.

Study Timeline

• Study Start: 2018-04
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications

Exclusion Criteria

• history of cervical trauma
• baseline dysphagia
• age less than 18 years old
• history of previous anterior neck surgery
• Creatinine clearance less than 30
• Creatinine greater than 1.0
• baseline sodium greater than 145
• patients with known electrolyte abnormalities
• congestive heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% sodium chloride	3% Sodium Chloride	Subjects in this group will receive 3% sodium chloride over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.
Normal Saline	Normal Saline	This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.

Primary Outcome Measures

Name	Time	Method
Post-operative dysphagia	Change in dysphagia scores will be assessed from pre-operative baseline value to: post-operative day one value, 2 week value, 6 week value, and 12 week value.	Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as "none", "mild", "moderate", and "severe".