Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414879
• Other study ID #: FMASU R3/2018
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2018
• Est. completion date: July 25, 2019

Study information

• Verified date: November 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Ketamine
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..
• Lidocaine
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

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of supplemental lidocaine	Dose of supplemental lidocaine during awake fiberoptic procedure	Intraoperative
Secondary	Incidence of adverse events	The incidence of adverse events related to the procedure and study drugs will be recorded	Intraoperative
Secondary	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
Secondary	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