Trial | NCT03318471  Report issue

Title

Magnesium Sulphate for Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application
The Effect of Intravenous Single Dose of Magnesium Sulphate on Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application During Craniotomies

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.
Background: Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.

Methods: This randomized, double blind, and prospective study was done in Neurosurgical department at ElSahel Teaching Hospital in Cairo from February 2016 till august 2017. All adult patients aged from 18 to 60 years of both genders, ASA physical status I and II scheduled for craniotomies were assessed to enter this study. Seventy one patients were assessed preoperatively, sixty of them were enrolled and assigned in two groups (n=30 each). Group M received 50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes. Group S received 100ml 0.9% Sodium Chloride over the same period with the same rate.Mean HR was recorded as a primary outcome , meanwhile; MAP and the need for a bolus dose of fentanyl was considered a secondary outcome.
Study Started
Feb 29
2016
Primary Completion
Aug 31
2017
Study Completion
Oct 01
2017
Last Update
Oct 24
2017

Drug MgSo4

50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes

  • Other names: magnesium sulphate

Drug 0.9% NaCl

100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes

  • Other names: normal saline

Group M Active Comparator

received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes

Group S Placebo Comparator

received 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes.

Criteria 

Inclusion Criteria:

All adult patients aged from 18 to 60 years
of both genders
ASA physical status I and II
scheduled for craniotomies

Exclusion Criteria:

history of MgSo4 consumption or allergy
renal disease
hepatic or endocrine disorder
cardiovascular dysfunction
calcium channel blocker intake
drug abuse were excluded from this study.
No Results Posted