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.

Not Applicable

Completed

• Conditions: Spinal Surgery
• Interventions: Other: 0.9% normal saline; Other: plasmalyte

• Registration Number: NCT01855542
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-13
• Last Update Submitted: 2013-05-13
• Study First Posted: 2013-05-16
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% saline	0.9% normal saline	In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
plasmalyte	plasmalyte	In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.

Primary Outcome Measures

Name	Time	Method
base-excess	Change from baseline in base-excess at postoperative 12 h

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of