Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

Arsil Radiansyah

Status and phase: Completed; Phase 1

Conditions: Intubation Complication

Treatments: Drug: saline solution; Drug: Lidocaine IV; Drug: Magnesium Sulfate 20 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT06516861

USumateraUtara01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

MgSO4 intravenous

Experimental group

Description:

Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery

Treatment:

Drug: Magnesium Sulfate 20 MG/ML

Lidocaine intravenous

Experimental group

Description:

Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery

Treatment:

Drug: Lidocaine IV

NaCl 0,9% Intravenous

Placebo Comparator group

Description:

Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery

Treatment:

Drug: saline solution