Clinical trial NCT06516861: Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intubation Complication
Keywords: Craniotomy
Intubation
Lidocaine
MgSO4
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
Collaborators: name: Universitas Sumatera Utara
First posted: 2024-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of this study used a double-blind randomized controlled clinical trial with pre test post test with control group design, to assess the comparison of hemodynamics and post-intubation cortisol in the administration of intravenous Magnesium sulfate and intravenous Lidocaine. The study sample was all patients who underwent surgery who met the inclusion and exclusion criteria.
Primary purpose: PREVENTION

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 month
measure: Diastolic Blood Pressure
timeFrame: 1 month
measure: Mean Arterial Pressure (MAP)
timeFrame: 1 month
measure: Heart Rate
timeFrame: 1 month
Secondary outcomes:
measure: Cortisol Levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Adam Malik General Hospital
state: Sumatera Utara
Study officials:
affiliation: Universitas Sumatera Utara
name: Rr Sinta Irina, MD
role: STUDY_CHAIR
References:
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