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Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis

Primary Purpose

Nebulization, Spray-as-You-Go, Dexmedetomidine

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nebulization
Spray-as-you-go
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nebulization

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age from 21to 65 years. Both sexes. American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective surgery requiring general anesthesia , and known to have Temporomandibular joint ankylosis and expected to be difficult intubation patient due to restriction of jaw mobility and limited mouth opening less than 2 fingers. Exclusion Criteria: History of allergy to dexmedetomidine or lidocaine. History of drug abuse. Concomitant use of medications which may exaggerate the heart rate (HR) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), HR <50 beats/min, systolic blood pressure (SBP) <90 mmHg. Pregnancy. Morbid obesity( BMI more than 35). Patients on anticoagulants, nasal trauma, deformity or polyp, CSF rhinorrhea, fracture base skull. Cardiac and/or respiratory disease, reactive airway disease, hepatic or renal disorders.

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group N (Nebulization group)

Group S (Spray-as-you-go)

Arm Description

Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg nebulization + saline 10 ml via spray-as-you-go technique.

Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization.

Outcomes

Primary Outcome Measures

Ease of successful intubation
Ease of successful intubation will be measured by the composite score which is a composite of five parameters with a score of 1-5 for each parameter, 1 indicating best possible condition and higher scores indicating worsening of the conditions for intubation . The maximum score was 25. A score of <10 was considered optimal, 10-15

Secondary Outcome Measures

Adverse events.
Adverse events (bradycardia, hypotension, laryngeal spasm, lidocaine toxicity). Hypotension (MAP < 20% of baseline readings ). Bradycardia (HR < 50 beats/min
Time till successful intubation.
Time needed till successful intubation. Direct visualization of the endotracheal tube passing through the vocal cords into the trachea.
Post-operative sore throat.
Sore throat will be evaluated at PACU 1, 12 and 24h after extubation, during the post-operative period. Grading of Post-operative sore throat (POST) will be done using a four-point scale (0-3) : 0 for no sore throat; 1 for mild sore throat (complains of sore throat only when asked); 2 for moderate sore throat (complains of sore throat even without asking); and 3 for severe sore throat (with change of voice or hoarseness, also may be associated with throat pain).

Full Information

First Posted
October 3, 2023
Last Updated
October 18, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06088875
Brief Title
Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis
Official Title
Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis: A Randomized Double-Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in TMJ ankylosis patients.
Detailed Description
Awake fiber-optic intubation (AFOI) has become the accepted gold standard technique for management of recognized difficult airway as the larynx remains in a posterior position and the patient is able to protect the airway from soiling and can maintain the airway patency as well as spontaneous breathing efforts. Awake intubation requires that the patient remains calm and cooperative and is provided with sufficient anxiolysis, analgesia, and topical anesthesia without compromising the airway. Gag reflex, cough, and laryngospasm can be upsetting during the process. Awake patients never permit airway instrumentation without airway anesthesia. Therefore, effective airway anesthesia is required for airway instrumentation and patient comfort. For awake intubation, topical airway anesthesia can be provided either by using fiberoptic bronchoscope (FOB) to apply local anaesethic to the airway by a "spray-as-you-go" technique or nebulizing the patient for about 10-15 min.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nebulization, Spray-as-You-Go, Dexmedetomidine, Lidocaine, Temporomandibular Ankylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group N (Nebulization group)
Arm Type
Experimental
Arm Description
Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg nebulization + saline 10 ml via spray-as-you-go technique.
Arm Title
Group S (Spray-as-you-go)
Arm Type
Experimental
Arm Description
Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization.
Intervention Type
Drug
Intervention Name(s)
Nebulization
Intervention Description
Patients will be nebulized with mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg by using wall nebulizer for 15 min before awake fiberoptic intubation. Patients in group S will receive saline 10 ml nebulization
Intervention Type
Drug
Intervention Name(s)
Spray-as-you-go
Intervention Description
Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. Patients in group N will receive saline via spray-as-you-go technique
Primary Outcome Measure Information:
Title
Ease of successful intubation
Description
Ease of successful intubation will be measured by the composite score which is a composite of five parameters with a score of 1-5 for each parameter, 1 indicating best possible condition and higher scores indicating worsening of the conditions for intubation . The maximum score was 25. A score of <10 was considered optimal, 10-15
Time Frame
Immediately after intubation
Secondary Outcome Measure Information:
Title
Adverse events.
Description
Adverse events (bradycardia, hypotension, laryngeal spasm, lidocaine toxicity). Hypotension (MAP < 20% of baseline readings ). Bradycardia (HR < 50 beats/min
Time Frame
From intervention for 4hours
Title
Time till successful intubation.
Description
Time needed till successful intubation. Direct visualization of the endotracheal tube passing through the vocal cords into the trachea.
Time Frame
Immediately after intubation
Title
Post-operative sore throat.
Description
Sore throat will be evaluated at PACU 1, 12 and 24h after extubation, during the post-operative period. Grading of Post-operative sore throat (POST) will be done using a four-point scale (0-3) : 0 for no sore throat; 1 for mild sore throat (complains of sore throat only when asked); 2 for moderate sore throat (complains of sore throat even without asking); and 3 for severe sore throat (with change of voice or hoarseness, also may be associated with throat pain).
Time Frame
24 hours after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 21to 65 years. Both sexes. American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective surgery requiring general anesthesia , and known to have Temporomandibular joint ankylosis and expected to be difficult intubation patient due to restriction of jaw mobility and limited mouth opening less than 2 fingers. Exclusion Criteria: History of allergy to dexmedetomidine or lidocaine. History of drug abuse. Concomitant use of medications which may exaggerate the heart rate (HR) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), HR <50 beats/min, systolic blood pressure (SBP) <90 mmHg. Pregnancy. Morbid obesity( BMI more than 35). Patients on anticoagulants, nasal trauma, deformity or polyp, CSF rhinorrhea, fracture base skull. Cardiac and/or respiratory disease, reactive airway disease, hepatic or renal disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud H El-Baradei, MBBCH
Phone
00201150242991
Email
mahmoud.elbaradei74@gmail.com
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud H El-Baradei, MBBCH
Phone
00201150242991
Email
mahmoud.elbaradei74@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed S El-gebaly, MD
First Name & Middle Initial & Last Name & Degree
Rehab S El Kalla, MD
First Name & Middle Initial & Last Name & Degree
Motaz M Abu Sabaa, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis

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