Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery
Primary Purpose
Dysphagia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
3% Sodium Chloride
Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Dysphagia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
3% sodium chloride
Normal Saline
Arm Description
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.
This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT03677310
First Posted
September 14, 2018
Last Updated
April 1, 2019
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03677310
Brief Title
Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Resident physician decided not to proceed with study
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
There is no effective treatment for post-operative dysphagia. Thus crossover is not expected.
Masking
ParticipantInvestigator
Masking Description
The bags of IV solution will be masked by the pharmacists before sending to the operating room.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3% sodium chloride
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Sham Comparator
Arm Description
This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.
Intervention Type
Drug
Intervention Name(s)
3% Sodium Chloride
Intervention Description
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
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.
Primary Outcome Measure Information:
Title
Post-operative dysphagia
Description
Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as "none", "mild", "moderate", and "severe".
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Tanaka, MD
Organizational Affiliation
University of Missouri Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery
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