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

El-Sahel Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Supratentorial Brain Tumor

Treatments: Drug: 0.9% NaCl; Drug: MgSo4

Study type: Interventional

Funder types: Other

Identifiers

NCT03318471

2017101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group M

Active Comparator group

Description:

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

Treatment:

Drug: MgSo4

Group S

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% NaCl