NCT04695613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 3, 2021

Last Update Submit

May 27, 2021

Conditions

Shivering Control

Outcome Measures

Primary Outcomes (1)

  • Postoperative shivering grade

    "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 Outcomes (2)

  • Shivering frequency

    2 hours postoperative

  • Blood loss volume

    2 hours postoperative

Study Arms (2)

aminoacid group

ACTIVE COMPARATOR

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

Drug: Aminoacid

magnesium sulfate group

ACTIVE COMPARATOR

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

Drug: Magnesium sulfate

Interventions

AminoacidDRUG

amino acid infusion 150 ml/kg/hr starting preoperative

aminoacid group
Magnesium sulfateDRUG

magnesium sulphate bolus and infusion 60 mg/kg starting preoperative

magnesium sulfate group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.

You may not qualify if:

  • Hepatic inefficiency
  • Renal inefficiency
  • Spinal anesthesia because of a different mechanism of hypothermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Amino AcidsMagnesium Sulfate

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 5, 2021

Study Start

January 3, 2021

Primary Completion

March 25, 2021

Study Completion

April 10, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations

EG(1)