Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

Ahmed Mohamed ELbadawy

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Craniotomy

Treatments: Drug: Normal saline; Drug: Lidocaine Hydrochloride; Drug: Magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03566329

N2011

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Magnesium sulphate

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium sulphate

lidocaine hydrochloride

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride

NaCl 0.9% normal saline

Placebo Comparator group

Description:

Normal saline infusion with the same rate as the study drugs

Treatment:

Drug: Normal saline