Clinical trial NCT05941767: Dexmedetomidine or Lidocaine for Lessening the Hemodynamic Responses to Laryngoscopy and Intubation
Official title: Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Keywords: Dexmedetomidine
Lidocaine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum cortisol levels.
timeFrame: Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.
measure: Change in mean arterial blood pressure (MAP) in mmHg.
timeFrame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
measure: Change in heart rate (HR) per minute.
timeFrame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
measure: Change in systolic blood pressure (SBP) in mmHg.
timeFrame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
measure: Change in diastolic blood pressure (DBP) in mmHg.
timeFrame: Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, Zagazig University
state: Al-Sharkia
Study officials:
affiliation: Professor of Anesthesia, Intensive Care and pain management
name: Zaki Saleh Taha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Anesthesia, Intensive Care and pain management
name: Yasser Mohamed Nasr, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.