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

Anesthesia Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05941767
• Other study ID #: Stress Response to intubation
• Status: Completed
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 3, 2024
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Drug:
• Dexmedetomidine nebulization
The patient will receive nebulized dexmedetomidine via face mask nebulizer 10 minutes before induction of general anesthesia.
• Lidocaine nebulization
The patient will receive nebulized lidocaine 4% (3 mg /kg) 10 minutes before induction of general anesthesia.
• Dexmedetomidine IV
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.
• Lidocaine IV
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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig University	Zagazig	Al-Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Mahajan L, Kaur M, Gupta R, Aujla KS, Singh A, Kaur A. Attenuation of the pressor responses to laryngoscopy and endotracheal intubation with intravenous dexmedetomidine versus magnesium sulphate under bispectral index-controlled anaesthesia: A placebo-controlled prospective randomised trial. Indian J Anaesth. 2018 May;62(5):337-343. doi: 10.4103/ija.IJA_1_18. — View Citation

Mahjoubifard M, Heidari M, Dahmardeh M, Mirtajani SB, Jahangirifard A. Comparison of Dexmedetomidine, Lidocaine, and Fentanyl in Attenuation Hemodynamic Response of Laryngoscopy and Intubation in Patients Undergoing Cardiac Surgery. Anesthesiol Res Pract. 2020 Jul 1;2020:4814037. doi: 10.1155/2020/4814037. eCollection 2020. — View Citation

Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20. — View Citation

Soltani Mohammadi S, Maziar A, Saliminia A. Comparing Clonidine and Lidocaine on Attenuation of Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Controlled Hypertensive Patients: A Randomized, Double-Blinded Clinical Trial. Anesth Pain Med. 2016 Mar 27;6(2):e34271. doi: 10.5812/aapm.34271. eCollection 2016 Apr. — View Citation

Sriramka B, Warsi ZH, Sahoo J. Effects of adding dexmedetomidine to nebulized lidocaine on control of hemodynamic responses to laryngoscopy and intubation: A randomized clinical trial. J Anaesthesiol Clin Pharmacol. 2023 Jan-Mar;39(1):11-17. doi: 10.4103/joacp.JOACP_93_21. Epub 2022 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum cortisol levels.	Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements.	Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.
Primary	Change in mean arterial blood pressure (MAP) in mmHg.	Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.	Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Primary	Change in heart rate (HR) per minute.	Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.	Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Primary	Change in systolic blood pressure (SBP) in mmHg.	Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.	Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Primary	Change in diastolic blood pressure (DBP) in mmHg.	Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.	Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.