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

NCT ID: NCT03677310

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-11-30

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.

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

3% Sodium Chloride

Intervention Type: DRUG

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.

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.

Group Type: SHAM_COMPARATOR

Normal Saline

Intervention Type: DRUG

Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomoko Tanaka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Hospital

Other Identifiers

2012482

Identifier Type: -

Identifier Source: org_study_id