Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study

Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,

Study Overview

• Status: Recruiting
• Conditions: To Measure Systolic Blood Pressure Postintubation
• Intervention / Treatment: Drug: Normal saline, Lidocaine, dexmetomidine

Detailed Description

This study will be conducted in the operating theatres of Cairo university hospitals.

Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:

Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dina Mahmoud Mohamed, Lecturer; Phone Number: MD 01005249134; Email: Dinamahmoud@kasralainy.edu.eg
• Study Contact Backup: Name: Amr H Sayed, Assistant professor; Phone Number: MD 01069338998; Email: amr.hussein.sayed@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Recruiting
    • Cairo University Hospitals
    • Contact: Dina M Mohamed, MD; Phone Number: MD 01005249134; Email: Dinamahmoud@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • ASA I,II

  • Age 18-60y
  • Patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre.

Exclusion Criteria:

• • Uncontrolled high blood pressure > 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.

  • Patients with the history of allergy to lidocaine or dexmedetomidine.
  • ASA III & IV.
  • Patients refuse to share in this study
  • Suspected difficult intubation that needs more than 2 trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C; Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation	Drug: Normal saline, Lidocaine, dexmetomidine; The study drug of each group will be sprayed into oropharynx, the vocal cords and tracheal tree 3 minutes after induction of anesthesia and 5 minutes before intubation.
Active Comparator: Group L; : : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation	Drug: Normal saline, Lidocaine, dexmetomidine; The study drug of each group will be sprayed into oropharynx, the vocal cords and tracheal tree 3 minutes after induction of anesthesia and 5 minutes before intubation.
Active Comparator: Group D; will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.	Drug: Normal saline, Lidocaine, dexmetomidine; The study drug of each group will be sprayed into oropharynx, the vocal cords and tracheal tree 3 minutes after induction of anesthesia and 5 minutes before intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure systolic blood pressure immediately after intubation.	Using invasive blood pressure monitoring	Immediately after endotracheal intubation

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 10, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: N-258-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No