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CompletedNCT04659057Updated Jul 13, 2021

Nebulized Lidocaine, Dexmedetomedine and Their Combination in Direct Laryngoscopy Surgery

A Phase 4 interventional study of Nebulized Lidocaine and Nebulized dexmedetomidine in Hemodynamic Instability, sponsored by Ain Shams University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. The primary outcome of this study is to compare the effect of premedication with nebulized lidocaine, dexmedetomidine, combination of both to placebo on haemodynamic response during DL procedures.

Read the detailed description

Patients will be transferred to the induction room 30 min prior to surgery. Standard monitors will be applied [pulse oximetry, non invasive blood pressure (NIBP) and electrocardiogram (ECG)]. Basal HR, systolic (SBP), diastolic (DBP) and mean arterial blood pressure (MAP) will be recorded. An intravenous 22-G cannula will be inserted, and all patients will be pre-medicated with intravenous midazolam 0.02 mg/kg, granisetrone 2mg and ranitidine 30 mg.

Patients will then be randomly and evenly allocated to one of 4 groups (45 patients each).

Nebulized solutions will be prepared by a pharmacist not participating in the study. Nebulization will be done with 100% oxygen (10 L/min) through facemask attached to a nebulizer. Patients will be asked to breath normally. Nebulization will continue till the solution in the nebulizer is all aerosolized.

Upon arrival to the operating room, routine monitors will be applied in addition to neuromuscular monitor and end tidal CO2 (ETCO2). General anaesthesia will be induced, after 5 min of preoxygenation, by intravenous fentanyl 1 μg/kg, propofol 1.5-2 mg/kg titrated to a loss of verbal response and rocuronium 1 mg/kg to facilitate endotracheal intubation. Mackintosh laryngoscope will be introduced when train of four (TOF) count reaches 1. High volume-low pressure endotracheal tube (size 5-5.5) will be inserted by senior anaesthesiologist. HR, SBP, DBP and MAP will be recorded immediately after intubation.

Anaesthesia will be maintained by sevoflurane 2-3% in oxygen to air ratio 1:1. Rocuronium 0.1 mg/kg when required. Positive pressure ventilation will be set to maintain ETCO2 30-35 mmHg.

SBP, DBP, MAP and HR will be recorded on arrival to the induction room (baseline), after endotracheal intubation, and then every 5 min throughout the surgery.

In case of hypertension (defined as SBP > 140 mmHg, DBP >90 mmHg or MAP 20% higher than baseline) and/or tachycardia (defined as HR 20% higher than baseline), boluses fentanyl 0.5 μg/kg will be given with a maximum dose of 2 μg/Kg. If hypertension and/or tachycardia continue after reaching the maximum dose of fentanyl, loading dose of esmolol 500 μg/Kg will be started, followed by infusion of 100-300 μg/kg/min. The use and total dose of esmolol will be recorded.

In cases of significant hypotension (defined as mean blood pressure \< 70 mmHg), the patient will be treated initially with an intravenous (IV) fluid bolus of10 mL/kg normal saline, and if the condition persists, the patient will given 0.1-0.3 mg/kg IV ephedrine, which will be repeated every 3-5 minutes until the blood pressure is normalized. Significant bradycardia (defined as heart rate \< 60 beat/min) will be treated, when needed, with IV atropine 0.02 mg/kg.

At the conclusion of surgery, sevoflurane will be discontinued and patients will inhale 100% O2. After return of spontaneous breathing, residual neuromuscular block will be reversed with intravenous neostigmine 0.05 mg/kg and glycopyrolate 0.01 mg/kg. Extubation will be done when the patient starts to show purposeful movements.

02

Conditions studied

  • Hemodynamic Instability
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ASA I-III patients admitted for DL surgery.

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension (MAP > 100 mmHg) or ischaemic heart disease.
  • End stage renal impairment.
  • Chronic drug or alcohol abuse.
  • Predicted difficult airway, laryngoscopy and intubation time > 30 sec, more than one attempt of intubation.
  • Morbid obesity (BMI > 30).
  • Known allergy to the drugs used.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (actual)

Study arms

  • Active comparator
    Group L

    Lidocaine group; 45 randomly assigned patients.

    Drug: Nebulized Lidocaine

  • Active comparator
    Group D

    Demedetomidine group; 45 randomly assigned patients.

    Drug: Nebulized dexmedetomidine

  • Active comparator
    Group DL

    Combined lidocaine and dexmedetomidine group. 45 randomly assigned patients.

    Drug: Nebulized lidocaine and dexmedetomidine

  • Placebo comparator
    Group C

    Control group; 45 randomly assigned patients.

    Other: Placebo

Interventions

  • DrugNebulized Lidocaine

    will receive nebulized lidocaine 2%, 1 mg/kg with a maximum dose of 100 mg (5 ml).

    Also known as: Lidocaine group

  • DrugNebulized dexmedetomidine

    will receive nebulized dexmedetomidine (1 μg/kg diluted in 5 ml of saline 0.9%).

    Also known as: Dexmedetomidine group

  • DrugNebulized lidocaine and dexmedetomidine

    will receive nebulized lidocaine 2% (0.5 mg/kg) and dexmedetomidine 0.5 μg/kg dexmedetomidine in 5 ml of saline 0.9%.

    Also known as: Combined lidocaine and dexmedetomidine group

  • OtherPlacebo

    will receive nebulized saline 0.9% (5 ml) as control group.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Heart Rate

    Heart rate in beats/min

    Time frame: Every 5 minutes for 30-60minutes

  2. Systolic blood pressure

    Systolic blood pressure in mmHg

    Time frame: Every 5 minutes for 30-60 minutes

  3. Diastolic blood pressure

    Diastolic blood pressure in mmHg

    Time frame: Every 5 minutes for 30-60 minutes

  4. Mean arterial pressure

    Mean arterial pressure in mmHg

    Time frame: Every 5 min for 30-60 minutes

Secondary outcomes

  1. Total fentanyl and esmolol consumption

    The total dose of fentanyl and/or esmolol consumed by each patient

    Time frame: For 30-60 minutes

  2. recovery time

    The time from discontinuation of anaesthetic drugs until response to verbal commands

    Time frame: 5- 15 minutes

07

Study locations

2 sites
  • Ain Shams University
    Cairo, Cairo Governorate 11566, Egypt
  • Ain Shams University Hospitals
    Cairo, 11588, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04659057
Lead sponsor
Ain Shams University
Responsible party
Hala Salah El-Din El-Ozairy, MD (Lecturer of Anaesthesia, ICU and Pain management, Faculty of Medicine, Ain Shams University, Ain Shams University) — Principal investigator
First posted
Dec 9, 2020
Start date
Dec 12, 2020
Primary completion
Jul 11, 2021
Completion
Jul 11, 2021
Last update
Jul 13, 2021

Study contacts

Hala S El-Ozairy, MD
principal investigator · Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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