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NCT Number: NCT05941767

Dexmedetomidine or Lidocaine for Lessening the Hemodynamic Responses to Laryngoscopy and Intubation

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

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Key information

Conditions

Anesthesia Intubation Complication

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, 055, Egypt

About this study

Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The American Society of Anesthesiologists (ASA) physical status I & II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.

Mallampati grade I, II

Exclusion criteria

  • Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.

Treatment and study plan

Dexmedetomidine nebulization

Drug

The patient will receive nebulized dexmedetomidine via face mask nebulizer 10 minutes before induction of general anesthesia.

Other names: Precedex (200 mcg/2ml)

Lidocaine nebulization

Drug

The patient will receive nebulized lidocaine 4% (3 mg /kg) 10 minutes before induction of general anesthesia.

Other names: Lidocaine 2% (20 mg/ml)

Dexmedetomidine IV

Drug

The patient will receive intravenous infusion via a syringe pump of dexmedetomidine (1 ml= 4mcg) started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.

Other names: Precedex

Lidocaine IV

Drug

The patient will receive 1.5 mg/kg lidocaine 2% (1 ml = 20mg) completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.

Other names: Lidocaine 2% (20 mg/ml)

Primary outcomes

  1. Change in serum cortisol levels.

    Time frame: Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.

    Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements.

  2. Change in mean arterial blood pressure (MAP) in mmHg.

    Time frame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

    Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

  3. Change in heart rate (HR) per minute.

    Time frame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

    Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

  4. Change in systolic blood pressure (SBP) in mmHg.

    Time frame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

    Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

  5. Change in diastolic blood pressure (DBP) in mmHg.

    Time frame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2023
Registry last updated
Feb 28, 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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