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Clinical Trials/NCT01855542
NCT01855542CompletedNot Applicable

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.

Yonsei University1 site in 1 country50 target enrollmentStarted: March 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
base-excess
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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\ 145mEq/L)
  • •13. Hyperkalemia (K\>5.5mEq/L)
  • •14. psychological medication or any drugs that influences renal clearance

Arms & Interventions

0.9% saline

Experimental

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

Intervention: 0.9% normal saline (Other)

plasmalyte

Active Comparator

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

Intervention: plasmalyte (Other)

Outcomes

Primary Outcomes

base-excess

Time Frame: Change from baseline in base-excess at postoperative 12 h

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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