Skip to main content
OpenTrials
Completed

NCT Number: NCT04695613

Shivering Control After Percutaneous Nephrolithotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shivering Control

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminoacid

Drug

amino acid infusion 150 ml/kg/hr starting preoperative

Magnesium sulfate

Drug

magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

Primary outcomes

  1. 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 outcomes

  1. Shivering frequency

    Time frame: 2 hours postoperative

    Number of shivering episodes in postoperative period

  2. Blood loss volume

    Time frame: 2 hours postoperative

    Assessing blood loss in surgical drains postoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.