Magnesium Sulphate for Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application

Phase 4

Completed

• Conditions: Supratentorial Brain Tumor
• Interventions: Drug: 0.9% NaCl; Drug: MgSo4

• Registration Number: NCT03318471
• Lead Sponsor: El-Sahel Teaching Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-02
• Primary Completion: 2017-08
• Status Verified: 2017-10
• Study Completion: 2017-10-01
• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-10-18
• Last Update Submitted: 2017-10-18
• Study First Posted: 2017-10-24
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	0.9% NaCl	received 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes.
Group M	MgSo4	received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes

Primary Outcome Measures

Name	Time	Method
Mean HR	From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}	Mean heart rate/min.

Secondary Outcome Measures

Name	Time	Method
Need for a bolus opioid	from time of insertion over 30 minutes .	Need for a bolus fentanyl after pins insertion to alleviate pressor effects
MAP	From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}	Mean arterial Blood Pressure (mmHg)