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

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.

Study Overview

• Status: Completed
• Conditions: Supratentorial Brain Tumor
• Intervention / Treatment: Drug: MgSo4; Drug: 0.9% NaCl

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes	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
Placebo Comparator: Group S; received 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes.	Drug: 0.9% NaCl; 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean HR	Mean heart rate/min.	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'').}

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP	Mean arterial Blood Pressure (mmHg)	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'').}
Need for a bolus opioid	Need for a bolus fentanyl after pins insertion to alleviate pressor effects	from time of insertion over 30 minutes .

Collaborators and Investigators

• Sponsor: El-Sahel Teaching Hospital
• Investigators: Principal Investigator: Samir A ElKafrawy, MD, ElSahel Teaching hospital,Cairo

Publications and helpful links

General Publications

• 1. Gonzales RM, Masone RJ, Peterson R. Hemodynamic response to application of neurosurgical skull-pin head-holder. Anesth Rev. 1987; 14:53-4.
• Bithal PK, Dash HH, Chauhan R, Mohanty B. Haemodynamic changes in response to skull-pins application - Comparison between normotensive and hypertensive patients. Indian J Anaesth. 2002; 46:383-5.
• Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.
• Osborn I, Sebeo J. "Scalp block" during craniotomy: a classic technique revisited. J Neurosurg Anesthesiol. 2010 Jul;22(3):187-94. doi: 10.1097/ANA.0b013e3181d48846.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 14, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: MgSo4, Mayfield clamp, pressor effect
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 2017101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No