Shivering Control After Percutaneous Nephrolithotomy

NCT ID: NCT04695613

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-03
• Study Completion Date: 2021-04-10

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.

Conditions

Shivering Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

aminoacid group

patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia

Group Type: ACTIVE_COMPARATOR

Aminoacid

Intervention Type: DRUG

amino acid infusion 150 ml/kg/hr starting preoperative

magnesium sulfate group

patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type: DRUG

magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

Interventions

Aminoacid

amino acid infusion 150 ml/kg/hr starting preoperative

Intervention Type: DRUG

Magnesium sulfate

magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Makram Soliman

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

17300539

Identifier Type: -

Identifier Source: org_study_id