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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03318471
Enrollment
60
Registered
2017-10-24
Start date
2016-02-29
Completion date
2017-10-01
Last updated
2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Brain Tumor

Keywords

MgSo4, Mayfield clamp, pressor effect

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.

Interventions

DRUGMgSo4

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

DRUG0.9% NaCl

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

Sponsors

El-Sahel Teaching Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean HRFrom 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

MeasureTime frameDescription
MAPFrom 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)
Need for a bolus opioidfrom time of insertion over 30 minutes .Need for a bolus fentanyl after pins insertion to alleviate pressor effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026