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
About this trial
This is an interventional treatment trial for Supratentorial Brain Tumor focused on measuring MgSo4, Mayfield clamp, pressor effect
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.
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
NCT ID
NCT03318471
First Posted
October 14, 2017
Last Updated
October 18, 2017
Sponsor
El-Sahel Teaching Hospital
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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