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

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complication
• Interventions: Drug: Dexmedetomidine nebulization; Drug: Lidocaine IV; Drug: Lidocaine nebulization; Drug: Dexmedetomidine IV

• Registration Number: NCT05941767
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study Start: 2023-07-12
• Study First Posted: 2023-07-12
• Primary Completion: 2023-11-05
• Status Verified: 2024-01
• Study Completion: 2024-01-03
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine nebulization	Dexmedetomidine nebulization	The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction.
Lidocaine IV	Lidocaine IV	The patient will receive 1.5mg/kg intravenous lidocaine 2% completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.
Lidocaine Nebulization	Lidocaine nebulization	The patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.
Dexmedetomidine IV	Dexmedetomidine IV	The patient will receive an intravenous infusion of dexmedetomidine (1 ml= 4 mcg) via a syringe pump and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Change in mean arterial blood pressure (MAP) in mmHg.	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.
Change in heart rate (HR) per minute.	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.
Change in diastolic blood pressure (DBP) in mmHg.	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.
Change in systolic blood pressure (SBP) in mmHg.	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.
Change in serum cortisol levels.	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.

Trial Locations

Locations (1)

Faculty of medicine, Zagazig University; 🇪🇬 Zagazig, Al-Sharkia, Egypt