Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation

January 23, 2024 updated by: Nattawadee Phokaw, MD, Khon Kaen University

Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients

The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.

The main question it aims to answer is:

- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?

Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Anesthetic protocol

  • Preoperative

    • After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
    • No preoperative sedatives or analgesics were administered.

  • Intraoperative Pre-induction phase

    • Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
    • BIS (Bispectral index) was monitored
    • Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.

Intervention: prepared before induction anesthesia.

  • Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).
  • Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).

Induction phase

  • Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%
  • Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.
  • General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.
  • Bag mask ventilation will be started.
  • The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.
  • Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.
  • Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.

At 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.

  • Tracheal intubation will be performed.
  • The bispectral index (BIS) target range during intubation is 40 to 60.
  • The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period

All the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

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 Locations

  • Thailand
    • KhonKaen
      • Nai Muang, KhonKaen, Thailand, 40002
        • Khon Kaen University
        • Contact:
        • Principal Investigator:
          • Nattawadee Phokaw, M.D.
        • Sub-Investigator:
          • Cattleya Kasemsiri, M.D.
        • Sub-Investigator:
          • Narin Plailahan, M.D.
        • Sub-Investigator:
          • Apinya Kittiponghansa, M.D.
        • Sub-Investigator:
          • Pornthep Kasemsiri, M.D.
        • Sub-Investigator:
          • Thirada Jimarsa, B.N.
        • Sub-Investigator:
          • Wayuda Paksiri, B.N.
        • Sub-Investigator:
          • Darunee Sripadungkul, M.D.

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18-65 years old
  2. American Society of Anesthesiologists (ASA) physical status classification I-II

Exclusion Criteria:

  1. History of lidocaine allergy
  2. Predicted difficult airways
  3. Body mass index > 35 kilograms per meter squared
  4. Risk aspiration
  5. Baseline hemodynamic instability; heart rate < 50 bpm, heart rate > 120 bpm, blood pressure < 90/60 mmHg, blood pressure > 160/90 mmHg
  6. Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease
  7. Pregnancy
  8. Cerebral aneurysm, Arteriovenous malformation, Tumor size > 4 centimeters, Brain herniation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group SL
10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each.
Drug: lidocaine spray
Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg)
Other Names:
  • 10% lidocaine spray
Active Comparator: Group IL
2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
Drug: Intravenous Lidocaine
2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Other Names:
  • 2%Intravenous Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in mean arterial pressure (MAP) during the peri-intubation period
Time Frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Mean arterial pressure was recorded in mmHg by the anesthesiologist
T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Changing in blood pressure (BP) during the peri-intubation period
Time Frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Blood pressure was recorded in mmHg by the anesthesiologist
T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Changing in heart rate (HR) during the peri-intubation period
Time Frame: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Heart rate was recorded in bpm by the anesthesiologist
T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse event during laryngoscopy and intubation procedure
Time Frame: During laryngoscopy and intubation procedure
Adverse events were recorded by the anesthesiologist. The adverse events included coughing, desaturation, aspiration, hypotension, hypertension, tachycardia, and bradycardia
During laryngoscopy and intubation procedure

Collaborators and Investigators

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

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Nattawadee Phokaw, MD, Department of anesthesiologist, Faculty of Medicine, Khon Kaen University

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE661362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual participant data (IPD)

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

Researcher who required more information for further study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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