Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Lidocaine; Drug: Ketamine

• Registration Number: NCT03414879
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-01-27
• Study First Posted: 2018-01-30
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-24
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine	Nebulization with with lidocaine
Ketamine group	Ketamine	Nebulization with ketamine

Primary Outcome Measures

Name	Time	Method
Dose of supplemental lidocaine	Intraoperative	Dose of supplemental lidocaine during awake fiberoptic procedure

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Intraoperative	The incidence of adverse events related to the procedure and study drugs will be recorded
Patient tolerability score	Intraoperative	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.
Patient satisfaction score	first 24 hours	will be assessed against five point Likert score where (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt