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Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

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ClinicalTrials.gov Identifier: NCT06374017
Recruitment Status : Recruiting
First Posted : April 18, 2024
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Dina Mahmoud Mohamed, Kasr El Aini Hospital

Study Description
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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 ,

Condition or disease Intervention/treatment Phase
To Measure Systolic Blood Pressure Postintubation Drug: Normal saline, Lidocaine, dexmetomidine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study
Actual Study Start Date : September 20, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : May 10, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. To measure systolic blood pressure immediately after intubation. [ Time Frame: Immediately after endotracheal intubation ]
    Using invasive blood pressure monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06374017


Contacts
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Contact: Dina Mahmoud Mohamed, Lecturer 01005249134 ext MD Dinamahmoud@kasralainy.edu.eg
Contact: Amr H Sayed, Assistant professor 01069338998 ext MD amr.hussein.sayed@gmail.com

Locations
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Egypt
Cairo University hospitals Recruiting
Cairo, Egypt, 11559
Contact: Dina M Mohamed, MD    01005249134 ext MD    Dinamahmoud@kasralainy.edu.eg   
Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dina Mahmoud Mohamed, Lecturer of Anesthesia and Surgical ICU and pain management, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT06374017    
Other Study ID Numbers: N-258-2023
First Posted: April 18, 2024    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Systolic Murmurs
Heart Murmurs
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action