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Completed

NCT Number: NCT03414879

Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

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.

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Key information

Conditions

Anesthesia

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University hospitals

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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..

Other names: Ketalar

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

Other names: xylocaine

Primary outcomes

  1. Dose of supplemental lidocaine

    Time frame: Intraoperative

    Dose of supplemental lidocaine during awake fiberoptic procedure

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Intraoperative

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

  2. Patient satisfaction score

    Time frame: first 24 hours

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

  3. Patient tolerability score

    Time frame: 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).

    • 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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