Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

August 13, 2019 updated by: Ahmed Mohamed ELbadawy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Ahmed ELbadawy
        • Contact:
          • Ahmed ELbadawy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: 2 hours
Time till discharge from PACU
2 hours
Incidence of side effects of the used drugs
Time Frame: 4 hours
measure of safety
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Mohamed ELbadawy

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Magnesium sulphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe