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

NCT ID: NCT05941767

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-01-03

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.

Conditions

Anesthesia Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine nebulization

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine nebulization

Intervention Type: DRUG

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) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.

Group Type: ACTIVE_COMPARATOR

Lidocaine nebulization

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine IV

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: 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.

Interventions

Dexmedetomidine nebulization

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

Intervention Type: DRUG

Lidocaine nebulization

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Precedex (200 mcg/2ml); Lidocaine 2% (20 mg/ml); Precedex; Lidocaine 2% (20 mg/ml)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zaki Saleh Taha, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Anesthesia, Intensive Care and pain management

Yasser Mohamed Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Anesthesia, Intensive Care and pain management

Locations

Faculty of medicine, Zagazig University

Zagazig, Al-Sharkia, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 37250266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32434291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29910490 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27247914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32695159 (View on PubMed)

Other Identifiers

Stress Response to intubation

Identifier Type: -

Identifier Source: org_study_id