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

NCT06573957 | Completed DMC

• 1 other identifier: AN-202408.01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

Haemodynamic Response; Endotracheal Intubation; Dexmedetomidine; Lidocaine

Outcome Measures

Primary Outcomes (3)

• Systolic blood pressure

  Right after endotracheal intubation until 5 minutes after endotracheal intubation

• Diastolic blood pressure

  Right after endotracheal intubation until 5 minutes after endotracheal intubation

• Heart rate

  Right after endotracheal intubation until 5 minutes after endotracheal intubation

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocain

Interventions

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

Dexmedetomidine

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

Lidocaine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

RSUP Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: August 27, 2024
• Study Start: May 29, 2024
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

ID (1)