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OpenTrials
Completed

NCT Number: NCT01855542

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.

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • ASA class III or IV
  • pregnancy
  • breast feeding
  • lack of mental weakness(including disabled)
  • using diuretics
  • respiratory insufficiency
  • metabolic acidosis or alkalosis
  • coagulation disorder
  • over hydtration
  • renal failure or serum creatinine > 1.4mg/dl
  • anemia (Hemoglobin 9.0<mg/dl)
  • hypernatremia (Na > 145mEq/L)
  • Hyperkalemia (K>5.5mEq/L)
  • psychological medication or any drugs that influences renal clearance

Treatment and study plan

0.9% normal saline

Other

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

plasmalyte

Other

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

Primary outcomes

  1. base-excess

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2013
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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