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.

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01855542

Collaborator

(none)

Enrollment

Location

Arms

10.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Surgery	Other: 0.9% normal saline Other: plasmalyte	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 0.9% saline

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

Other: 0.9% normal saline

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

Active Comparator: plasmalyte

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

Other: plasmalyte

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

Outcome Measures

Primary Outcome Measures

base-excess [Change from baseline in base-excess at postoperative 12 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01855542

Other Study ID Numbers:

4-2012-0059

First Posted:

May 16, 2013

Last Update Posted:

May 16, 2013

Last Verified:

May 1, 2013

Keywords provided by Yonsei University

metabolic acidosis, plasmalyte solution, 0.9% normal saline

Additional relevant MeSH terms:

Plasma-lyte 148

Study Results

No Results Posted as of May 16, 2013