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Completed

NCT Number: NCT06573957

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

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.

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Key information

Conditions

General Anesthesia

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUP Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

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

Lidocain

Drug

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

Primary outcomes

  1. Systolic blood pressure

    Time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation

  2. Diastolic blood pressure

    Time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation

  3. Heart rate

    Time frame: Right after endotracheal intubation until 5 minutes after endotracheal intubation

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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