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The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.

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Yonsei University

Status

Completed

Conditions

Spinal Surgery

Treatments

Other: plasmalyte
Other: 0.9% normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01855542
4-2012-0059

Details and patient eligibility

About

Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.

Enrollment

50 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.

Exclusion criteria

  1. ASA class III or IV
  2. pregnancy
  3. breast feeding
  4. lack of mental weakness(including disabled)
  5. using diuretics
  6. respiratory insufficiency
  7. metabolic acidosis or alkalosis
  8. coagulation disorder
  9. over hydtration
  10. renal failure or serum creatinine > 1.4mg/dl
  11. anemia (Hemoglobin 9.0<mg/dl)
  12. hypernatremia (Na > 145mEq/L)
  13. Hyperkalemia (K>5.5mEq/L)
  14. psychological medication or any drugs that influences renal clearance

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

0.9% saline
Experimental group
Description:
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Treatment:
Other: 0.9% normal saline
plasmalyte
Active Comparator group
Description:
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Treatment:
Other: plasmalyte

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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