Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2018
CompletedFirst Submitted
Initial submission to the registry
January 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2019
CompletedNovember 26, 2019
November 1, 2019
1.5 years
January 21, 2018
November 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Dose of supplemental lidocaine
Dose of supplemental lidocaine during awake fiberoptic procedure
Intraoperative
Secondary Outcomes (3)
Incidence of adverse events
Intraoperative
Patient satisfaction score
first 24 hours
Patient tolerability score
Intraoperative
Study Arms (2)
Ketamine group
ACTIVE COMPARATORNebulization with ketamine
Lidocaine group
ACTIVE COMPARATORNebulization with with lidocaine
Interventions
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..
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University hospitals
Cairo, 11591, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 21, 2018
First Posted
January 30, 2018
Study Start
January 15, 2018
Primary Completion
July 25, 2019
Study Completion
July 25, 2019
Last Updated
November 26, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share