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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dysphagia
• Intervention / Treatment: Drug: 3% Sodium Chloride; Drug: Normal Saline

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 Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
SHAM_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative dysphagia	Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as "none", "mild", "moderate", and "severe".	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.

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Tomoko Tanaka, MD, University of Missouri Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2012482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes