Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Study Overview
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Brief Summary
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This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Detailed Description
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Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB) This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Official Title
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Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Ketamine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications). Exclusion Criteria: body weight < 60 kg or > 90 kg uncooperative, with mental or psychological problems known allergy to any of the study drugs pregnancy hypertension cardiac disease liver or renal impairment epilepsy, asthmatic, previous bad experience of awake intubation, emergency operations or coagulation abnormalities

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine group<br>Nebulization with ketamine | Drug: Ketamine<br>* While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..<br>* Other names: Ketalar;|
| Active Comparator: Lidocaine group<br>Nebulization with with lidocaine | Drug: Lidocaine<br>* While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation<br>* Other names: xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of supplemental lidocaine | Dose of supplemental lidocaine during awake fiberoptic procedure | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | The incidence of adverse events related to the procedure and study drugs will be recorded | Intraoperative | 
| Patient satisfaction score | will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent). | first 24 hours | 
| Patient tolerability score | Patient tolerability during the procedure will be rated as 4-point scale where 0= procedure totally intolerable with severe patient resistance (struggling/withdrawal movements). procedure partially tolerable with moderate patient resistance (restlessness/ verbal objection). procedure quiet tolerable with minimal patient resistance (just grimacing). procedure tolerable with no patient resistance. this score will be recorded at points during the intubation procedure: nasal passage, oro/hypopharynx, glottis and tube insertion. | Intraoperative |