Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.

NCT ID: NCT06651905

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Superior laryngeal nerve block

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Sedation arm; Nerve Block arm

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Zayed

Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Abd EL Halim Kaddah, MD

Role: STUDY_DIRECTOR

Professor

Mai M EL Rawas, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MS-484-2023

Identifier Type: -

Identifier Source: org_study_id