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Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

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ClinicalTrials.gov Identifier: NCT03414879
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Ahmad Alsayed Abdellatif, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Ketamine Drug: Lidocaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketamine group
Nebulization with ketamine
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..
Other Name: Ketalar

Active Comparator: Lidocaine group
Nebulization with with lidocaine
Drug: 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
Other Name: xylocaine




Primary Outcome Measures :
  1. Dose of supplemental lidocaine [ Time Frame: Intraoperative ]
    Dose of supplemental lidocaine during awake fiberoptic procedure


Secondary Outcome Measures :
  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).

    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.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414879


Locations
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Egypt
Ain Shams University hospitals
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Ayman Ahmad Alsayed Abdellatif, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03414879    
Other Study ID Numbers: FMASU R3/2018
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents