NCT03318471

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

October 14, 2017

Last Update Submit

October 18, 2017

Conditions

Supratentorial Brain Tumor

Keywords

MgSo4, Mayfield clamp, pressor effect

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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'').}

  • Need for a bolus opioid

    from time of insertion over 30 minutes .

Study Arms (2)

Group M

ACTIVE COMPARATOR

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

Drug: MgSo4

Group S

PLACEBO COMPARATOR

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

Drug: 0.9% NaCl

Interventions

MgSo4DRUG

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

Also known as: magnesium sulphate
Group M
0.9% NaClDRUG

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

Also known as: normal saline
Group S

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All adult patients aged from 18 to 60 years
  • of both genders
  • ASA physical status I and II
  • scheduled for craniotomies

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 1. Gonzales RM, Masone RJ, Peterson R. Hemodynamic response to application of neurosurgical skull-pin head-holder. Anesth Rev. 1987; 14:53-4.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26903671BACKGROUND

  • 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.

    PMID: 20479675BACKGROUND

MeSH Terms

Interventions

Magnesium SulfateSaline Solution

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Samir A ElKafrawy, MD

    ElSahel Teaching hospital,Cairo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of Anesthesia & Pain Relief

Study Record Dates

First Submitted

October 14, 2017

First Posted

October 24, 2017

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10