Intubation Complication
Conditions
Keywords
Craniotomy, Intubation, Lidocaine, MgSO4
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).
Interventions
DRUGMagnesium Sulfate 20 MG/ML
Administered intravenously with a dose of 30 mg/kg
DRUGLidocaine IV
Administered intravenously with a dose of 1.5mg/Kg
DRUGsaline solution
Administered intravenously with 20 ml
Sponsors
Universitas Sumatera Utara
Arsil Radiansyah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
masks the subjects and care provider from knowing which study treatment
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cortisol Levels | 1 month | Cortisol Levels in nmol/L |
Countries
Indonesia
Outcome results
None listed