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
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Ketamine Drug: Lidocaine||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
Active Comparator: Ketamine group
Nebulization with 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
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
- Dose of supplemental lidocaine [ Time Frame: Intraoperative ]Dose of supplemental lidocaine during awake fiberoptic procedure
- 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).
- 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.
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
|Ain Shams University hospitals|
|Cairo, Egypt, 11591|