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

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ClinicalTrials.gov Identifier: NCT03318471
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Samir Ahmed Ahmed ElKafrawy, 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.

Condition or disease Intervention/treatment Phase
Supratentorial Brain Tumor Drug: MgSo4 Drug: 0.9% NaCl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Single Dose of Magnesium Sulphate on Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application During Craniotomies
Actual Study Start Date : February 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: normal saline




Primary Outcome Measures :
  1. Mean HR [ Time Frame: 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 :
  1. MAP [ Time Frame: 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)

  2. Need for a bolus opioid [ Time Frame: from time of insertion over 30 minutes . ]
    Need for a bolus fentanyl after pins insertion to alleviate pressor effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318471


Sponsors and Collaborators
El-Sahel Teaching Hospital
Investigators
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Principal Investigator: Samir A ElKafrawy, MD ElSahel Teaching hospital,Cairo

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.

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Responsible Party: Samir Ahmed Ahmed ElKafrawy, Fellow of Anesthesia & Pain Relief, El-Sahel Teaching Hospital
ClinicalTrials.gov Identifier: NCT03318471    
Other Study ID Numbers: 2017101
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samir Ahmed Ahmed ElKafrawy, El-Sahel Teaching Hospital:
MgSo4, Mayfield clamp, pressor effect
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Magnesium Sulfate
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents