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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

Tracking Information
First Submitted Date  ICMJE January 21, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE January 15, 2018
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
Dose of supplemental lidocaine [ Time Frame: Intraoperative ]
Dose of supplemental lidocaine during awake fiberoptic procedure
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
  • Incidence of adverse events [ Time Frame: Intraoperative ]
    The incidence of adverse events related to the procedure and study drugs will be recorded
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2018)
  • Incidence of adverse events [ Time Frame: Intraoperative ]
    The incidence of adverse events related to the procedure and study drugs will be recorded
  • Patient satisfaction score [ Time Frame: first 24 hours ]
    will be assessed against five point Likert score where (1: excellent, 2: very good, 3: good, 4: fair, 5: poor).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation
Official Title  ICMJE Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Ketamine group
    Nebulization with ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: Lidocaine group
    Nebulization with with lidocaine
    Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2019)
60
Original Actual Enrollment  ICMJE
 (submitted: January 27, 2018)
30
Actual Study Completion Date  ICMJE July 25, 2019
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03414879
Other Study ID Numbers  ICMJE FMASU R3/2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Ahmad Alsayed Abdellatif, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP