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

NCT05941767 | Completed

• 1 other identifier: Stress Response to intubation
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Intubation Complication

Keywords

Dexmedetomidine; Lidocaine

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

Dexmedetomidine nebulization

ACTIVE COMPARATOR

The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction.

Drug: Dexmedetomidine nebulization

Lidocaine Nebulization

ACTIVE COMPARATOR

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.

Drug: Lidocaine nebulization

Dexmedetomidine IV

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine IV

Lidocaine IV

ACTIVE COMPARATOR

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.

Drug: Lidocaine IV

Interventions

Dexmedetomidine nebulization DRUG

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

Also known as: Precedex (200 mcg/2ml)

Dexmedetomidine nebulization

Lidocaine nebulization DRUG

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

Also known as: Lidocaine 2% (20 mg/ml)

Lidocaine Nebulization

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.

Also known as: Precedex

Dexmedetomidine IV

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.

Also known as: Lidocaine 2% (20 mg/ml)

Lidocaine IV

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, 055, Egypt

Location

Related Publications (5)

• 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.

  PMID: 37250266 BACKGROUND

• 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.

  PMID: 32434291 BACKGROUND

• 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.

  PMID: 29910490 BACKGROUND

• 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.

  PMID: 27247914 BACKGROUND

• 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.

  PMID: 32695159 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Lidocaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Zaki Saleh Taha, MD

  Professor of Anesthesia, Intensive Care and pain management

  PRINCIPAL INVESTIGATOR

• Yasser Mohamed Nasr, MD

  Professor of Anesthesia, Intensive Care and pain management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 12, 2023
• Primary Completion: November 5, 2023
• Study Completion: January 3, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-01

Locations

EG (1)