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Completed

NCT Number: NCT06516861

Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Adam Malik General Hospital

Medan, North Sumatra, 20136, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium Sulfate 20 MG/ML

Drug

Administered intravenously with a dose of 30 mg/kg

Other names: Magnesium sulfate injection

Lidocaine IV

Drug

Administered intravenously with a dose of 1.5mg/Kg

Other names: Lidocaine

Saline Solution

Drug

Administered intravenously with 20 ml

Other names: NaCl 0,9% Solution

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 1 month

    mmHg

  2. Diastolic Blood Pressure

    Time frame: 1 month

    mmHg

  3. 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

  4. Heart Rate

    Time frame: 1 month

    beats per minute

Secondary outcomes

  1. Cortisol Levels

    Time frame: 1 month

    Cortisol Levels in nmol/L

Sponsors and collaborators

Lead sponsor

Arsil Radiansyah

Other

Collaborators

  • Universitas Sumatera Utara

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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