Anesthesia
Conditions
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.
Interventions
DRUGKetamine
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..
DRUGLidocaine
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of supplemental lidocaine | Intraoperative | Dose of supplemental lidocaine during awake fiberoptic procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Intraoperative | The incidence of adverse events related to the procedure and study drugs will be recorded |
| Patient satisfaction score | 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 | 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. |
Countries
Egypt
Outcome results
None listed