Shivering Control After Percutaneous Nephrolithotomy

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04695613
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 25.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shivering Control	Drug: Aminoacid; Drug: Magnesium sulfate	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering
• Actual Study Start Date: Jan 3, 2021
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Apr 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Shivering frequency [2 hours postoperative]

   Number of shivering episodes in postoperative period

2. Blood loss volume [2 hours postoperative]

   Assessing blood loss in surgical drains postoperative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Makram Soliman, lecturer of anesthesia, Assiut University
• ClinicalTrials.gov Identifier: NCT04695613
• Other Study ID Numbers: 17300539
• First Posted: Jan 5, 2021
• Last Update Posted: Jun 1, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Magnesium Sulfate

Study Results

No Results Posted as of Jun 1, 2021