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

NCT ID: NCT03318471

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-10-01

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.

Conditions

Supratentorial Brain Tumor

Keywords

MgSo4, Mayfield clamp, pressor effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group M

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

Group Type: ACTIVE_COMPARATOR

MgSo4

Intervention Type: DRUG

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

Group S

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

Group Type: PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type: DRUG

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

Interventions

MgSo4

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

Intervention Type: DRUG

0.9% NaCl

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

Intervention Type: DRUG

Other Intervention Names

magnesium sulphate; normal saline

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

El-Sahel Teaching Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Samir Ahmed Ahmed ElKafrawy

Fellow of Anesthesia & Pain Relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samir A ElKafrawy, MD

Role: PRINCIPAL_INVESTIGATOR

ElSahel Teaching hospital,Cairo

References

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

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26903671 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20479675 (View on PubMed)

Other Identifiers

2017101

Identifier Type: -

Identifier Source: org_study_id