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Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03566329
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 15, 2019
Information provided by (Responsible Party):
Ahmed Mohamed ELbadawy, Kasr El Aini Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Nacl

Primary Outcome Measures :
  1. postcraniotomy emergence hypertension response to the study drugs [ Time Frame: 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 [ Time Frame: 2 hours ]
    Time till discharge from PACU

  2. Incidence of side effects of the used drugs [ Time Frame: 4 hours ]
    measure of safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03566329

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Contact: Ahmed ELbadawy, MD 01064249076 ext 11562

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Ahmed ELbadawy Recruiting
Cairo, Egypt, 02
Contact: Ahmed ELbadawy         
Sponsors and Collaborators
Ahmed Mohamed ELbadawy
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Principal Investigator: Ahmed ELbadawy, MD Faculty of medicine- Cairo University- Egypt

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Responsible Party: Ahmed Mohamed ELbadawy, Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini Hospital Identifier: NCT03566329     History of Changes
Other Study ID Numbers: N2011
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Mohamed ELbadawy, Kasr El Aini Hospital:
craniotomy- Emergence- hypertension
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Magnesium Sulfate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents