Shivering Control After Percutaneous Nephrolithotomy

Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04695613

Enrollment

Registered

2021-01-05

Start date

2021-01-03

Completion date

2021-04-10

Last updated

2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shivering Control

Brief summary

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

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

DRUGAminoacid

amino acid infusion 150 ml/kg/hr starting preoperative

DRUGMagnesium sulfate

magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative shivering grade	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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026