Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

NCT ID: NCT03566329

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2019-12-31

Brief Summary

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Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.

Detailed Description

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Conditions

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Craniotomy Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Magnesium sulphate

50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion

Group Type ACTIVE_COMPARATOR

Magnesium sulphate

Intervention Type DRUG

Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .

lidocaine hydrochloride

1.5mg/kg loading followed by 2mg/kg/hr infusion

Group Type ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type DRUG

lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion

NaCl 0.9% normal saline

Normal saline infusion with the same rate as the study drugs

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline infusion with the same rate of infusion as the study drugs

Interventions

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Magnesium sulphate

Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .

Intervention Type DRUG

Lidocaine Hydrochloride

lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion

Intervention Type DRUG

Normal saline

Normal saline infusion with the same rate of infusion as the study drugs

Intervention Type DRUG

Other Intervention Names

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Xylocaine Nacl

Eligibility Criteria

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Inclusion Criteria

* ASA physical status Ι or Π.
* scheduled patients for brain tumor excision.

Exclusion Criteria

* Hepatic, renal, cardiac, pulmonary, or endocrine impairment.
* Signs of increased intracranial pressure or allergy to any of the used drugs.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmed Mohamed ELbadawy

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed ELbadawy

Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed ELbadawy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine- Cairo University- Egypt

Locations

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Ahmed ELbadawy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed ELbadawy, MD

Role: CONTACT

01064249076 ext. 11562

Facility Contacts

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Ahmed ELbadawy

Role: primary

Other Identifiers

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N2011

Identifier Type: -

Identifier Source: org_study_id

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