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

Primary Purpose

Supratentorial Brain Tumor

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MgSo4
0.9% NaCl
Sponsored by
El-Sahel Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supratentorial Brain Tumor focused on measuring MgSo4, Mayfield clamp, pressor effect

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group M

    Group S

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Mean HR
    Mean heart rate/min.

    Secondary Outcome Measures

    MAP
    Mean arterial Blood Pressure (mmHg)
    Need for a bolus opioid
    Need for a bolus fentanyl after pins insertion to alleviate pressor effects

    Full Information

    First Posted
    October 14, 2017
    Last Updated
    October 18, 2017
    Sponsor
    El-Sahel Teaching Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03318471
    Brief Title
    Magnesium Sulphate for Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application
    Official Title
    The Effect of Intravenous Single Dose of Magnesium Sulphate on Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application During Craniotomies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    October 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    El-Sahel Teaching Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Supratentorial Brain Tumor
    Keywords
    MgSo4, Mayfield clamp, pressor effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group M
    Arm Type
    Active Comparator
    Arm Description
    received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes
    Arm Title
    Group S
    Arm Type
    Placebo Comparator
    Arm Description
    received 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    MgSo4
    Other Intervention Name(s)
    magnesium sulphate
    Intervention Description
    50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% NaCl
    Other Intervention Name(s)
    normal saline
    Intervention Description
    100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes
    Primary Outcome Measure Information:
    Title
    Mean HR
    Description
    Mean heart rate/min.
    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'').}
    Secondary Outcome Measure Information:
    Title
    MAP
    Description
    Mean arterial Blood Pressure (mmHg)
    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'').}
    Title
    Need for a bolus opioid
    Description
    Need for a bolus fentanyl after pins insertion to alleviate pressor effects
    Time Frame
    from time of insertion over 30 minutes .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samir A ElKafrawy, MD
    Organizational Affiliation
    ElSahel Teaching hospital,Cairo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    1. Gonzales RM, Masone RJ, Peterson R. Hemodynamic response to application of neurosurgical skull-pin head-holder. Anesth Rev. 1987; 14:53-4.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26903671
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20479675
    Citation
    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.
    Results Reference
    background

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

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