Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-03-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

masks the subjects and care provider from knowing which study treatment

Study Groups

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MgSO4 intravenous

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

Group Type EXPERIMENTAL

Magnesium Sulfate 20 MG/ML

Intervention Type DRUG

Administered intravenously with a dose of 30 mg/kg

Lidocaine intravenous

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

Group Type EXPERIMENTAL

Lidocaine IV

Intervention Type DRUG

Administered intravenously with a dose of 1.5mg/Kg

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

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

Administered intravenously with 20 ml

Interventions

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Magnesium Sulfate 20 MG/ML

Administered intravenously with a dose of 30 mg/kg

Intervention Type DRUG

Lidocaine IV

Administered intravenously with a dose of 1.5mg/Kg

Intervention Type DRUG

saline solution

Administered intravenously with 20 ml

Intervention Type DRUG

Other Intervention Names

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Magnesium sulfate injection Lidocaine NaCl 0,9% Solution

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes