Back to resultsMagnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension
Primary Purpose
Craniotomy, Hypertension
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium sulphate
Lidocaine Hydrochloride
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Craniotomy focused on measuring craniotomy- Emergence- hypertension
Eligibility 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.
Sites / Locations
- Ahmed ELbadawyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Magnesium sulphate
lidocaine hydrochloride
NaCl 0.9% normal saline
Arm Description
50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion
1.5mg/kg loading followed by 2mg/kg/hr infusion
Normal saline infusion with the same rate as the study drugs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Recovery time
Time till discharge from PACU
Incidence of side effects of the used drugs
measure of safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566329
Brief Title
Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension
Official Title
Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed ELbadawy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniotomy, Hypertension
Keywords
craniotomy- Emergence- hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulphate
Arm Type
Active Comparator
Arm Description
50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion
Arm Title
lidocaine hydrochloride
Arm Type
Active Comparator
Arm Description
1.5mg/kg loading followed by 2mg/kg/hr infusion
Arm Title
NaCl 0.9% normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline infusion with the same rate as the study drugs
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate
Intervention Description
Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
Xylocaine
Intervention Description
lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Nacl
Intervention Description
Normal saline infusion with the same rate of infusion as the study drugs
Primary Outcome Measure Information:
Title
postcraniotomy emergence hypertension response to the study drugs
Description
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
Time Frame
4hours
Secondary Outcome Measure Information:
Title
Recovery time
Description
Time till discharge from PACU
Time Frame
2 hours
Title
Incidence of side effects of the used drugs
Description
measure of safety
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed ELbadawy, MD
Phone
01064249076
Ext
11562
Email
elbadawyahmed89@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed ELbadawy, MD
Organizational Affiliation
Faculty of medicine- Cairo University- Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed ELbadawy
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed ELbadawy
12. IPD Sharing Statement
Learn more about this trial
Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension
We'll reach out to this number within 24 hrs