Shivering Control After Percutaneous Nephrolithotomy

Phase 3

Completed

• Conditions: Shivering Control
• Interventions: Drug: Aminoacid; Drug: Magnesium sulfate

• Registration Number: NCT04695613
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2021-01-03
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Primary Completion: 2021-03-25
• Study Completion: 2021-04-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aminoacid group	Aminoacid	patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia
magnesium sulfate group	Magnesium sulfate	patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt