Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

Phase 1

Completed

• Conditions: Intubation Complication
• Interventions: Drug: Magnesium Sulfate 20 MG/ML; Drug: Lidocaine IV; Drug: saline solution

• Registration Number: NCT06516861
• Lead Sponsor: Arsil Radiansyah

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).

Study Timeline

• Study Start: 2024-01-31
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-01
• Study First Submitted: 2024-06-23
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4 intravenous	Magnesium Sulfate 20 MG/ML	Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
Lidocaine intravenous	Lidocaine IV	Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
NaCl 0,9% Intravenous	saline solution	Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	1 month	mmHg
Diastolic Blood Pressure	1 month	mmHg
Mean Arterial Pressure (MAP)	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
Heart Rate	1 month	beats per minute

Secondary Outcome Measures

Name	Time	Method
Cortisol Levels	1 month	Cortisol Levels in nmol/L

Trial Locations

Locations (1)

Adam Malik General Hospital; 🇮🇩 Medan, Sumatera Utara, Indonesia