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

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University of Missouri (MU)

Status and phase

Withdrawn
Phase 1

Conditions

Dysphagia

Treatments

Drug: Normal Saline
Drug: 3% Sodium Chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03677310
2012482

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

3% sodium chloride
Experimental group
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.
Treatment:
Drug: 3% Sodium Chloride
Normal Saline
Sham Comparator group
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.
Treatment:
Drug: Normal Saline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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