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NCT03566329 Clinical Trial

Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

Hypertension Clinical Trial

Official title:
Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03566329
Other study ID # N2011
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 10, 2018
Est. completion date December 2019

Study information
Verified date August 2019
Source Kasr El Aini Hospital
Contact Ahmed ELbadawy, MD
Phone 01064249076
Email elbadawyahmed89@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- ASA physical status ? or ?.

- 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• Normal saline
Normal saline infusion with the same rate of infusion as the study drugs

Locations
Country Name City State
Egypt Ahmed ELbadawy Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ahmed Mohamed ELbadawy

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary postcraniotomy emergence hypertension response to the study drugs 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 4hours
Secondary Recovery time Time till discharge from PACU 2 hours
Secondary Incidence of side effects of the used drugs measure of safety 4 hours
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