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

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ClinicalTrials.gov Identifier: NCT03677310
Recruitment Status : Withdrawn (Resident physician decided not to proceed with study)
First Posted : September 19, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysphagia Drug: 3% Sodium Chloride Drug: Normal Saline Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There is no effective treatment for post-operative dysphagia. Thus crossover is not expected.
Masking: Double (Participant, Investigator)
Masking Description: The bags of IV solution will be masked by the pharmacists before sending to the operating room.
Primary Purpose: Prevention
Official Title: The Effects of 3% Sodium Chloride on Post-operative Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: a Prospective, Randomized Double-blind Trial
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative dysphagia [ Time Frame: 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".


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677310


Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Tomoko Tanaka, MD University of Missouri Hospital
More Information
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03677310    
Other Study ID Numbers: 2012482
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases