Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    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 (DRUG)
    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

Condition or Disease

  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 50 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Jan 15, 2018 ACTUAL
    Primary Completion: Jul 25, 2019 ACTUAL
    Completion Date: Jul 25, 2019 ACTUAL
    Study First Posted: Jan 30, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 24, 2019

    Sponsors / Collaborators

    Lead Sponsor: Ain Shams University
    Responsible Party: N/A

    Location

    Cairo, Egypt

    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.

    Participant Groups

    • Nebulization with ketamine

    • Nebulization with with lidocaine

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Dose of supplemental lidocaine during awake fiberoptic procedure

    Secondary Outcomes

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

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

    • 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.

    More Details

    NCT Number: NCT03414879
    Other IDs: FMASU R3/2018
    Study URL: https://clinicaltrials.gov/study/NCT03414879
    Last updated: Sep 29, 2023