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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Withdrawn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
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 14, 2018
    Last Updated
    April 1, 2019
    Sponsor
    University of Missouri-Columbia
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    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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