Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

July 17, 2024 updated by: Arsil Radiansyah

Comparison of Magnesium Sulphate 30 mg/Kg With Lidocaine 1,5 mg/Kg in Hemodynamic Changes and Cortisol Level Post-intubation in Patient Undergoing Craniotomy

The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The sample was randomly divided into 3 groups and divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. The first group of patients was given Magnesium Sulfate 30 mg /kg diluted in 20 ml with NaCl 0.9%, labeled with code A, and given in 5 minutes with a syringe pump, The second group was given Lidocaine 1.5 mg/kg diluted in 20 ml with NaCl 0.9%, labeled with code B and given in 5 minutes with a syringe pump, The third group was given NaCl 0.9%, in a 20 ml syringe labeled with code C and given in 5 minutes with a syringe pump. After induction and intubation, patients were then recorded systolic blood pressure, diastolic blood pressure, MAP, and pulse at T1 (3 minutes), T2 (5 minutes), T3 (7 minutes), and T4 (10 minutes).

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Indonesia
    • Sumatera Utara
      • Medan, Sumatera Utara, Indonesia, 20136
        • Adam Malik General Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients aged 18-65 years;
  • body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2;
  • patients or their families agreed to be used as research subjects;
  • elective non-traumatic craniotomy cases, namely supratentorial brain tumor evacuation, intracerebral hemorrhage evacuation, subdural hemorrhage, cerebrovascular correction.

Exclusion Criteria:

  • cardiac, hepatic, and renal disorders;
  • patients with pregnancy;
  • hypertension or hypotension before surgery;
  • hypersensitivity to Magnesium Sulfate and/or Lidocaine;
  • patients with chronic use of corticosteroid drugs, calcium channel blockers, magnesium-containing drugs, and opioids;
  • risk of difficult intubation and ventilation according to the LEMON score and MOANS score criteria;
  • impaired cortisol secretion (pituitary tumor or hypothalamic tumor or adrenal gland disorder); and
  • patients with hypocortisol or hypercortisol at T0 serum cortisol examination.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MgSO4 intravenous
Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
Drug: Magnesium Sulfate 20 MG/ML
Administered intravenously with a dose of 30 mg/kg
Other Names:
  • Magnesium sulfate injection
Experimental: Lidocaine intravenous
Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
Drug: Lidocaine IV
Administered intravenously with a dose of 1.5mg/Kg
Other Names:
  • Lidocaine
Placebo Comparator: NaCl 0,9% Intravenous
Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery
Drug: saline solution
Administered intravenously with 20 ml
Other Names:
  • NaCl 0,9% Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 1 month
mmHg
1 month
Diastolic Blood Pressure
Time Frame: 1 month
mmHg
1 month
Mean Arterial Pressure (MAP)
Time Frame: 1 month
Estimated by using a formula in which the lower (diastolic) blood pressure is doubled and added to the higher (systolic) blood pressure and that composite sum then is divided by 3 to estimate MAP
1 month
Heart Rate
Time Frame: 1 month
beats per minute
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol Levels
Time Frame: 1 month
Cortisol Levels in nmol/L
1 month

Collaborators and Investigators

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

Sponsor

Arsil Radiansyah

Collaborators

Universitas Sumatera Utara

Investigators

  • Study Chair: Rr Sinta Irina, MD, Universitas Sumatera Utara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 31, 2024

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USumateraUtara01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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