Dexmedetomidine or Lidocaine for Attenuating the Hemodynamic Responses to Laryngoscopy and Intubation

Sponsor
Zagazig University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05941767
Collaborator
(none)
92
1
4
6
15.4

Study Details

Study Description

Brief Summary

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nebulized Dexmedetomidine
  • Drug: Nebulized Lidocaine
  • Drug: Intravenous Dexmedetomidine
  • Drug: Intravenous Lidocaine
N/A

Detailed Description

Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Nebulized Versus Intravenous Either Dexmedetomidine or Lidocaine for Attenuating the Hemodynamic Responses to Laryngoscopy and Intubation
Anticipated Study Start Date :
Jul 12, 2023
Anticipated Primary Completion Date :
Dec 12, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nebulized Dexmedetomidine

The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia, and to avoid bias normal saline infusion via 50 ml syringe pump will be started 20 minutes before induction, and 10 ml normal saline 0.9% bolus will be given 90 seconds before laryngoscopy.

Drug: Nebulized Dexmedetomidine
The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.
Other Names:
  • Precedex (200 mcg/2ml)
  • Active Comparator: Nebulized Lidocaine

    The patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia, and to avoid bias normal saline infusion via 50 ml syringe pump will be started 20 minutes before induction, and 10 ml normal saline 0.9% bolus will be given 90 seconds before laryngoscopy.

    Drug: Nebulized Lidocaine
    The patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.
    Other Names:
  • Debocaine (Lidocaine HCl) 2% (20 mg/ml) 50 ml (Multiple-Dose) Solution
  • Active Comparator: Intravenous Dexmedetomidine

    The patient will receive an intravenous infusion of dexmedetomidine (200 mcg/2ml) added to 48 ml normal saline 0.9% (1 ml= 4mcg) via syringe pump, and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia, and to avoid bias 3 ml normal saline 0.9% via face mask nebulizer will be started 10 minutes before induction. Also, 10 ml normal saline 0.9% will be given as an IV bolus 90 seconds before laryngoscopy.

    Drug: Intravenous Dexmedetomidine
    The patient will receive intravenous infusion via syringe pump of dexmedetomidine (200 mcg/2ml) added to 48 ml normal saline 0.9% ((1 ml= 4mcg)) started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.
    Other Names:
  • Precedex
  • Active Comparator: Intravenous Lidocaine

    The patient will receive intravenous lidocaine 2% ( 1.5mg/kg) completed to 10 ml with normal saline 0.9% (1 ml = 20mg) and will be given as intravenous bolus 90 seconds before induction of general anesthesia. To avoid bias, 3 ml normal saline 0.9% via face mask nebulizer will be started 10 minutes before induction. Also, normal saline 0.9% infusion will be started via a 50 ml syringe pump 20 minutes before laryngoscopy.

    Drug: Intravenous Lidocaine
    The patient will receive intravenous lidocaine 2% (1 ml = 20mg) in a dose of (1.5mg/kg) completed to 10 ml with normal saline 0.9% given as intravenous bolus 90 seconds before induction of general anesthesia.
    Other Names:
  • Lidocaine 2% (20 mg/ml)
  • Outcome Measures

    Primary Outcome Measures

    1. Change in serum cortisol levels. [Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.]

      Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements.

    2. Change in mean arterial blood pressure (MAP) in mmHg. [Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.]

      Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    3. Change in heart rate (HR) per minute. [Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.]

      Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    4. Change in systolic blood pressure (SBP) in mmHg. [Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.]

      Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

    5. Change in diastolic blood pressure (DBP) in mmHg. [Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.]

      Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA I & ASA II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.

    Mallampatti grade I ,II

    Exclusion Criteria:
    • Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine, Zagazig University Zagazig Al-Sharkia Egypt 055

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Zaki Saleh Taha, MD, Professor of Anesthesia, Intensive Care and pain management
    • Principal Investigator: Yasser Mohamed Nasr, MD, Professor of Anesthesia, Intensive Care and pain management

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05941767
    Other Study ID Numbers:
    • Stress Response to intubation
    First Posted:
    Jul 12, 2023
    Last Update Posted:
    Jul 12, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2023