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Completed

NCT Number: NCT06651905

Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.

This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.

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Key information

Conditions

Superior Laryngeal Nerve Block Anticipated Difficult Airway Awake Fiberoptic Intubation Dexmedetomidine Hemimandibulectomy Sedation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 11796, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range ≥ 18 or ≤60.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) II-III.
  • Body mass index:18.5 to 30 kg/m2.
  • Hemimandibulectomy patients with an anticipated difficult airway [El-Ganzouri Risk Index (EGRI)>3].

Exclusion criteria

  • Patient's refusal.
  • Known allergy to drugs used in the study.
  • Neurological disorders.
  • Advanced liver or kidney disease.
  • Patient with psychiatric disorders.
  • Patient who needs postoperative ICU.
  • Airway distortion and cervical spine movement.

Treatment and study plan

Dexmedetomidine

Drug

The patients were given 0.5 mcg /kg dexmedetomidine over 10 min via syringe pump, followed by 0.2-0.7 mcg/kg/hour until the end of intubation according to hemodynamics.

Other names: Sedation arm

superior laryngeal nerve block

Drug

The patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.

Other names: Nerve Block arm

Primary outcomes

  1. The intubation score

    Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes

    The intubation conditions score is assessed based on the following criteria:

    (i) Vocal movement: 1 = open, 2 = moving, 3 = closing, 4 = closed. (ii) Coughing: 1 = none, 2 = slight, 3 = moderate, 4 = severe. (iii) Limb movement: 1 = none, 2 = slight, 3 = moderate, 4 = severe.

    Where The Intubation conditions score is :

    Excellent = 1 when all qualities are excellent. Good = 2 when all qualities are either excellent or good. Poor = 3 when the presence of a single poor quality is noted.

Secondary outcomes

  1. The degree of comfort

    Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes

    The comfort score was evaluated using a five-point fiberoptic intubation comfort scale: 1 = no reaction, 2 = slight grimace, 3 = heavy grimace, 4 = verbal objection, and 5 = defensive movement of head and hands.

  2. Degree of airway obstruction

    Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes

    The degree of airway obstruction (1 - absent, 2 - requiring neck extension, 3 - requiring jaw thrust) was noted

  3. Heart rate

    Time frame: From one minute before intubation to 10 minutes after intubation

    Heart rate is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.

  4. Mean arterial pressure

    Time frame: From one minute before intubation till10 minutes after intubation

    Mean arterial blood pressure is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.

  5. Ramsay sedation score

    Time frame: From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation

    Ramsay sedation score was recorded as follows: 1: Awake, agitated or restless or both; 2: Awake, cooperative, oriented, and tranquil; 3: Awake but responds to commands only; 4: Asleep, with a brisk response to a light glabellar tap or loud auditory stimulus.

  6. Patient satisfaction score

    Time frame: From the end of the operation to 24 hours postoperative

    The patient satisfaction score (1-excellent, 2-good, 3-reasonable, 4-poor) was documented.

  7. Incidence of complications

    Time frame: From the end of the operation to 24 hours postoperative

    Adverse events such as bradycardia, hypotension, nausea, vomiting, pruritus, respiratory depression, O2 desaturation, or any other complications were recorded.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 23, 2024

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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