Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

Phase 1

• Conditions: Hypertension; Craniotomy
• Interventions: Drug: Normal saline; Drug: Magnesium sulphate; Drug: Lidocaine Hydrochloride

• Registration Number: NCT03566329
• Lead Sponsor: Ahmed Mohamed ELbadawy

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-25
• Study Start: 2018-07-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9% normal saline	Normal saline	Normal saline infusion with the same rate as the study drugs
Magnesium sulphate	Magnesium sulphate	50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion
lidocaine hydrochloride	Lidocaine Hydrochloride	1.5mg/kg loading followed by 2mg/kg/hr infusion

Primary Outcome Measures

Name	Time	Method
postcraniotomy emergence hypertension response to the study drugs	4hours	The number of the patients who have systolic blood pressure below 140 mmH during emergence of anesthesia after craniotomy for brain tumors in each group

Secondary Outcome Measures

Name	Time	Method
Recovery time	2 hours	Time till discharge from PACU
Incidence of side effects of the used drugs	4 hours	measure of safety

Trial Locations

Locations (1)

Ahmed ELbadawy; 🇪🇬 Cairo, Egypt