Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

• Sponsor: Ahmed Mohamed ELbadawy (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03566329
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 16.7
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy; Hypertension	Drug: Magnesium sulphate; Drug: Lidocaine Hydrochloride; Drug: Normal saline	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)
• Actual Study Start Date: Jul 10, 2018
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion	Drug: Magnesium sulphate; Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .
Active Comparator: lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion	Drug: Lidocaine Hydrochloride; lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion; Other Names: Xylocaine
Placebo Comparator: NaCl 0.9% normal saline Normal saline infusion with the same rate as the study drugs	Drug: Normal saline; Normal saline infusion with the same rate of infusion as the study drugs; Other Names: Nacl

Outcome Measures

Primary Outcome Measures

1. 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

1. Recovery time [2 hours]

   Time till discharge from PACU

2. Incidence of side effects of the used drugs [4 hours]

   measure of safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed ELbadawy	Cairo		Egypt	02

Sponsors and Collaborators

• Ahmed Mohamed ELbadawy

Investigators

• Principal Investigator: Ahmed ELbadawy, MD, Faculty of medicine- Cairo University- Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed ELbadawy, Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT03566329
• Other Study ID Numbers: N2011
• First Posted: Jun 25, 2018
• Last Update Posted: Aug 15, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Mohamed ELbadawy, Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini Hospital: craniotomy- Emergence- hypertension
• Additional relevant MeSH terms: Hypertension; Lidocaine; Magnesium Sulfate

Study Results

No Results Posted as of Aug 15, 2019