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Completed

NCT Number: NCT04659057

Nebulized Lidocaine, Dexmedetomedine and Their Combination in Direct Laryngoscopy Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University, Cairo, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III patients admitted for DL surgery.

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.

Treatment and study plan

Nebulized Lidocaine

Drug

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

Other names: Lidocaine group

Nebulized Dexmedetomidine

Drug

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

Other names: Dexmedetomidine group

Nebulized lidocaine and dexmedetomidine

Drug

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

Other names: Combined lidocaine and dexmedetomidine group

Placebo

Other

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

Other names: Control group

Primary outcomes

  1. Heart Rate

    Time frame: Every 5 minutes for 30-60minutes

    Heart rate in beats/min

  2. Systolic blood pressure

    Time frame: Every 5 minutes for 30-60 minutes

    Systolic blood pressure in mmHg

  3. Diastolic blood pressure

    Time frame: Every 5 minutes for 30-60 minutes

    Diastolic blood pressure in mmHg

  4. Mean arterial pressure

    Time frame: Every 5 min for 30-60 minutes

    Mean arterial pressure in mmHg

Secondary outcomes

  1. Total fentanyl and esmolol consumption

    Time frame: For 30-60 minutes

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

  2. recovery time

    Time frame: 5- 15 minutes

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Nebulized Lidocaine, Dexmedetomedine and Their Combination on Haemodynamics During Direct Laryngoscopy Surgery. A Randomized Controlled Clinical Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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