NCT03677310

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

The Effects of 3% Sodium Chloride on Post-operative Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: a Prospective, Randomized Double-blind Trial

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DRUG	3% Sodium Chloride	3% sodium chloride will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.
DRUG	Normal Saline	Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2018-09-19
• Last updated: 2019-04-03

Regulatory

• FDA-regulated drug study