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.

Spinal Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855542
• Other study ID #: 4-2012-0059
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: May 13, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Surgery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	base-excess		Change from baseline in base-excess at postoperative 12 h	No