Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

Kasr El Aini Hospital

Status and phase: Completed; Phase 4

Conditions: To Measure Systolic Blood Pressure Postintubation

Treatments: Drug: Normal saline, Lidocaine, dexmetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06374017

N-258-2023

Details and patient eligibility

About

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 ,

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline, Lidocaine, dexmetomidine

Group L

Active Comparator group

Description:

: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation

Treatment:

Drug: Normal saline, Lidocaine, dexmetomidine

Group D

Active Comparator group

Description:

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.

Treatment:

Drug: Normal saline, Lidocaine, dexmetomidine