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

February 25, 2024 updated by: Zagazig University

Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayoub Mohammed Masoud Khayr, M.B.B.Ch

Study Locations

  • Egypt
    • Al-Sharkia
      • Zagazig, Al-Sharkia, Egypt, 055
        • Faculty of medicine, Zagazig university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The American Society of Anesthesiologists (ASA) physical status I & II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.

Mallampati grade I, II

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine nebulization
The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction.
Drug: Dexmedetomidine nebulization
The patient will receive nebulized dexmedetomidine via face mask nebulizer 10 minutes before induction of general anesthesia.
Other Names:
  • Precedex (200 mcg/2ml)
Active Comparator: Lidocaine Nebulization
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.
Drug: Lidocaine nebulization
The patient will receive nebulized lidocaine 4% (3 mg /kg) 10 minutes before induction of general anesthesia.
Other Names:
  • Lidocaine 2% (20 mg/ml)
Active Comparator: Dexmedetomidine IV
The patient will receive an intravenous infusion of dexmedetomidine (1 ml= 4 mcg) via a syringe pump and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.
Drug: Dexmedetomidine IV
The patient will receive intravenous infusion via a syringe pump of dexmedetomidine (1 ml= 4mcg) started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.
Other Names:
  • Precedex
Active Comparator: Lidocaine IV
The patient will receive 1.5mg/kg intravenous lidocaine 2% completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.
Drug: Lidocaine IV
The patient will receive 1.5 mg/kg lidocaine 2% (1 ml = 20mg) completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.
Other Names:
  • Lidocaine 2% (20 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum cortisol levels.
Time Frame: 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.
Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.
Change in mean arterial blood pressure (MAP) in mmHg.
Time Frame: 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.
Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Change in heart rate (HR) per minute.
Time Frame: 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.
Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Change in systolic blood pressure (SBP) in mmHg.
Time Frame: 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.
Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.
Change in diastolic blood pressure (DBP) in mmHg.
Time Frame: 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.
Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Actual)

November 5, 2023

Study Completion (Actual)

January 3, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stress Response to intubation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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