Shivering Control After Percutaneous Nephrolithotomy

May 27, 2021 updated by: Omar Makram Soliman, Assiut University

Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2021

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

April 10, 2021

Study Registration Dates

First Submitted

January 3, 2021

First Submitted That Met QC Criteria

January 3, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300539

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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