Clinical trial NCT06573957: Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response
Official title: Comparison of the Effects of Intravenous Administration of Dexmedetomidine 0.5 μg/kg Body Weight With Intravenous Lidocaine 1.5 mg/kg Body Weight on Blood Pressure and Heart Rate Response During Laryngoscopy and Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Haemodynamic Response
Endotracheal Intubation
Dexmedetomidine
Lidocaine
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.

Detailed description: Dexmedetomidine works very selectively on noradrenergic receptors distributed both within and outside the central nervous system, particularly in the pons and medulla. Presynaptic stimulation of α2 receptors can reduce the release of norepinephrine and the activation of postsynaptic α2 receptors. Lidocaine works by inhibiting sodium channels within cells, preventing the occurrence of action potentials and the transmission of impulses along nerves. Lidocaine also acts by blocking calcium and potassium channels as well as N-methyl-D-aspartate (NMDA) receptors.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-59 years.
* Patients scheduled for oral intubation.
* Physical status ASA I and II (American Society of Anesthesiologists).
* Patients with Mallampati classification I-II.

Exclusion Criteria:

* History of allergy to the drugs that will be used.
* Pregnant patients.
* Patients taking medications that affect blood pressure and heart rate, such as vasodilators, adrenergic blockers, antiarrhythmics, and cardiac stimulants.
* Patients with arrhythmias, AV block, liver disorders, hypertension, and hypoalbuminemia.
* Patients who have been given opioids within the last 24 hours.
* Patients with predicted intubation difficulties.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Right after endotracheal intubation until 5 minutes after endotracheal intubation
measure: Diastolic blood pressure
timeFrame: Right after endotracheal intubation until 5 minutes after endotracheal intubation
measure: Heart rate
timeFrame: Right after endotracheal intubation until 5 minutes after endotracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: RSUP Dr. Hasan Sadikin
state: West Java
Study officials:
References: