Shivering Control After Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.

Detailed Description
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A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.

Official Title
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Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering

Conditions
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Shivering Control

Intervention / Treatment
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* Drug: Aminoacid
* Drug: Magnesium sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia. Exclusion Criteria: Hepatic inefficiency Renal inefficiency Spinal anesthesia because of a different mechanism of hypothermia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aminoacid group<br>patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia | Drug: Aminoacid<br>* amino acid infusion 150 ml/kg/hr starting preoperative<br>|
| Active Comparator: magnesium sulfate group<br>patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia | Drug: Magnesium sulfate<br>* magnesium sulphate bolus and infusion 60 mg/kg starting preoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative shivering grade | grading of shivering, in which shivering degree was assessed as 1 of 5 levels (0, 1, 2, 3, and 4), grade 0 lack of shivering, grade 1 slight shivering (inconsiderable yet apparent peripheral vasoconstriction), grade 2 medium level shivering (muscular activity in one muscle group only) grade 3 severe shivering (muscular activity in more than one muscle group without generalized shivering) and grade 4 generalized shivering. | 2 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shivering frequency | Number of shivering episodes in postoperative period | 2 hours postoperative | 
| Blood loss volume | Assessing blood loss in surgical drains postoperative | 2 hours postoperative |