Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

Phase 4

Completed

• Conditions: To Measure Systolic Blood Pressure Postintubation
• Interventions: Drug: Normal saline, Lidocaine, dexmetomidine

• Registration Number: NCT06374017
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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 ,

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 Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-04-20
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Normal saline, Lidocaine, dexmetomidine	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	Normal saline, Lidocaine, dexmetomidine	: : 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	Normal saline, Lidocaine, dexmetomidine	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.

Primary Outcome Measures

Name	Time	Method
To measure systolic blood pressure immediately after intubation.	Immediately after endotracheal intubation	Using invasive blood pressure monitoring

Trial Locations

Locations (1)

Cairo University hospitals; 🇪🇬 Cairo, Egypt