Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.

NCT06651905 | Completed

• 1 other identifier: MS-484-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The degree of comfort

  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

  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

  From one minute before intubation to 10 minutes after intubation

• Mean arterial pressure

  From one minute before intubation till10 minutes after intubation

• Ramsay sedation score

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

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Superior laryngeal nerve block group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Sedation arm

Dexmedetomidine group

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.

Also known as: Nerve Block arm

Superior laryngeal nerve block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[El-Ganzouri Risk Index (EGRI)\>3\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11796, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tarek Abd EL Halim Kaddah, MD

  Professor

  STUDY DIRECTOR

• Mai M EL Rawas, MD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)