The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 11, 2024
First Posted Date  ICMJE April 18, 2024
Last Update Posted Date April 18, 2024
Actual Study Start Date  ICMJE September 20, 2023
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2024)		 To measure systolic blood pressure immediately after intubation. [ Time Frame: Immediately after endotracheal intubation ]
Using invasive blood pressure monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response
Official Title  ICMJE Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE To Measure Systolic Blood Pressure Postintubation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Normal saline, Lidocaine, dexmetomidine
  • 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
    Intervention: Drug: Normal saline, Lidocaine, dexmetomidine
  • 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.
    Intervention: Drug: Normal saline, Lidocaine, dexmetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2024)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06374017
Other Study ID Numbers  ICMJE N-258-2023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dina Mahmoud Mohamed, Kasr El Aini Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kasr El Aini Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kasr El Aini Hospital
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP