Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.

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

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

Study Overview

• Status: Completed
• Conditions: Sedation; Dexmedetomidine; Superior Laryngeal Nerve Block; Anticipated Difficult Airway; Awake Fiberoptic Intubation; Hemimandibulectomy
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Superior laryngeal nerve block

Detailed Description

Awake fiberoptic intubation (AFOI) has been recommended for adult patients with difficult airways. To make the process more tolerable, AFOI frequently requires sedation, anxiolysis, and hemodynamic stability without impairing ventilation and preserving spontaneous respiration. Intravenous dexmedetomidine, fentanyl, and midazolam are sedatives used during AFOI, commonly combined to decrease their side effects.

Dexmedetomidine is the drug of choice for many anesthesiologists for sedation in AFOI, as it produces sedation without respiratory depression in addition to its anxiolytic and analgesic properties. However, it can produce severe bradycardia and hypotension.

Airway nerve blocks are frequently used for AFOI, providing rapid and deep anesthesia. However, they carry a higher risk of complications, including nerve injury, intravascular injection, hematoma, or bleeding that may interfere with intubation. In addition, the presence of tumors or lymph nodes may not allow a successful block. To provide optimal airway anesthesia, it is advisable to block the superior laryngeal nerve (SLN) bilaterally and do the trans-tracheal injection for the recurrent laryngeal nerve.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Superior laryngeal nerve block group; Patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.	Drug: Superior laryngeal nerve block; 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
Experimental: Dexmedetomidine group; Patients were given 0.5 mcg/kg of dexmedetomidine over 10 minutes via a syringe pump, followed by a maintenance dose of 0.2-0.7 mcg/kg/hour until the end of intubation based on Hemodynamics.	Drug: Dexmedetomidine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intubation score	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of comfort	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.	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
Degree of airway obstruction	The degree of airway obstruction (1 - absent, 2 - requiring neck extension, 3 - requiring jaw thrust) was noted	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
Heart rate	Heart rate is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.	From one minute before intubation to 10 minutes after intubation
Mean arterial pressure	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.	From one minute before intubation till10 minutes after intubation
Ramsay sedation score	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.	From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation
Patient satisfaction score	The patient satisfaction score (1-excellent, 2-good, 3-reasonable, 4-poor) was documented.	From the end of the operation to 24 hours postoperative
Incidence of complications	Adverse events such as bradycardia, hypotension, nausea, vomiting, pruritus, respiratory depression, O2 desaturation, or any other complications were recorded.	From the end of the operation to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Tarek Abd EL Halim Kaddah, MD, Professor; Principal Investigator: Mai M EL Rawas, MD, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: MS-484-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No