Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03566329
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 15, 2019
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03566329


Contacts
Layout table for location contacts
Contact: Ahmed ELbadawy, MD 01064249076 ext 11562 elbadawyahmed89@yahoo.com

Locations
Layout table for location information
Egypt
Ahmed ELbadawy Recruiting
Cairo, Egypt, 02
Contact: Ahmed ELbadawy         
Sponsors and Collaborators
Ahmed Mohamed ELbadawy
Investigators
Layout table for investigator information
Principal Investigator: Ahmed ELbadawy, MD Faculty of medicine- Cairo University- Egypt

Layout table for additonal information
Responsible Party: Ahmed Mohamed ELbadawy, Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini Hospital
ClinicalTrials.gov 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

Layout table for additional information
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:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
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
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents