Shivering Control After Percutaneous Nephrolithotomy

Overview

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.

Full Title of Study: “Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 25, 2021

Detailed Description

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.

Interventions

  • Drug: Aminoacid
    • amino acid infusion 150 ml/kg/hr starting preoperative
  • Drug: Magnesium sulfate
    • magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

Arms, Groups and Cohorts

  • Active Comparator: aminoacid group
    • patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia
  • Active Comparator: magnesium sulfate group
    • patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative shivering grade
    • Time Frame: 2 hours postoperative
    • “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.

Secondary Measures

  • Shivering frequency
    • Time Frame: 2 hours postoperative
    • Number of shivering episodes in postoperative period
  • Blood loss volume
    • Time Frame: 2 hours postoperative
    • Assessing blood loss in surgical drains postoperative

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Omar Makram Soliman, lecturer of anesthesia – Assiut University

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