Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Ain Shams University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

KetamineDRUG

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..

LidocaineDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

Dose of supplemental lidocaine

Dose of supplemental lidocaine during awake fiberoptic procedure

Time frame: Intraoperative

Secondary Outcomes

Incidence of adverse events

The incidence of adverse events related to the procedure and study drugs will be recorded

Time frame: Intraoperative

Patient satisfaction score

will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).

Time frame: 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). 1. procedure partially tolerable with moderate patient resistance (restlessness/ verbal objection). 2. procedure quiet tolerable with minimal patient resistance (just grimacing). 3. 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.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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