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.

NCT ID: NCT01855542

Last Updated: 2013-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Spinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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0.9% saline

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

Group Type EXPERIMENTAL

0.9% normal saline

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

plasmalyte

Intervention Type OTHER

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

Interventions

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0.9% normal saline

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

Intervention Type OTHER

plasmalyte

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Song JW, Shim JK, Kim NY, Jang J, Kwak YL. The effect of 0.9% saline versus plasmalyte on coagulation in patients undergoing lumbar spinal surgery; a randomized controlled trial. Int J Surg. 2015 Aug;20:128-34. doi: 10.1016/j.ijsu.2015.06.065. Epub 2015 Jun 27.

Reference Type DERIVED
PMID: 26123384 (View on PubMed)

Other Identifiers

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4-2012-0059

Identifier Type: -

Identifier Source: org_study_id

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