Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response

NCT ID: NCT06573957

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2024-08-14

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.

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Twenty-one patients are administered dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before induction, then receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Patient in experimental arms will received intravenous dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before general anesthesia induction

Lidocaine

Twenty-one patients receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set, followed by lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation.

Group Type: ACTIVE_COMPARATOR

Lidocain

Intervention Type: DRUG

Patient in experimental arms will receive intravenous lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation

Interventions

Dexmedetomidine

Patient in experimental arms will received intravenous dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before general anesthesia induction

Intervention Type: DRUG

Lidocain

Patient in experimental arms will receive intravenous lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RSUP Dr. Hasan Sadikin

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

AN-202408.01

Identifier Type: -

Identifier Source: org_study_id