Alexandria University Faculty of Medicine
Alexandria, Alexandria Governorate, 21526, Egypt
NCT Number: NCT07743333
The current study is looked for the comparison between nebulized lidocaine and ketamine, nebulized lidocaine, and usual lidocaine spray in the oral and nasal cavities before flexible bronchoscopy. The investigators are looking for different outcomes including mainly cough suppression during the procedure, patient tolerance and discomfort, operator and patients' satisfaction, and safety of the use of these medications especially regarding nebulized ketamine.
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All sexes
Interventional
Phase 4
Alexandria, Alexandria Governorate, 21526, Egypt
The investigators conducted a case-control study that randomaly recruited patients planned for bronchoscopy irrespective to the cause. All the patients were recruited from bronchoscopy unit of Alexandria Main University hospital, Egypt. The patients were divided into 3 different groups and were given lidocaine alone (either nebulized or by Spary) or combined nebulized lidocaine-ketamine as premedication before flexible bronchoscopy. The nebulized medications were given by jet-nebulizer. All the patient underwent bronchoscopy under conscious sedation (midazolam, fentanyl with or without propofol) for bronchoalveolar lavage (BAL) with or without biopsy as planned before. All the patients were followed up before, during the bronchoscopy for vital signs (heart rate, blood pressure and O2 saturation "SpO2"), cough during and after the procedure that is scored, discomfort, sedation level using Ramsy sedation level, patient toleranceassessed using 11-point numeric rating scale (NRS) and pain assessed by the verbal rating scale (VRS). The time of the procedure was recorded for comparison. The dose of conscious sedation was calculated for each patient for later comparison. The patients were followed up the 2 hours after bronchoscopy for SpO2, heart rate, blood pressure, level of sedation and satisfaction that was assessed by patient Satisfaction Index (PSI).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This group received nebulization of lidocaine (dose of 60 mg) and ketamine (dose of 150 mg) each in separate nebulization before FOB as premedication. The patients were followed up before (just after nebulization), during and after FOB regarding hemodynamic satbility (as measured by blood pressure), heart rate and oxygen saturation.
Other names: interventional A Group
This group received nebulization of lidocaine (dose of 60 mg) only before FOB as premedication. The patients were followed up before, during and after FOB regarding hemodynamic satbility (measured by blood pressure), heart rate and O2 saturation.
This group received lidocaine spray (2%) alone for the oral and nasal cavities before FOB as premedication. The patients were followed up before, during and after FOB regarding hemodynamic satbility (measured by blood pressure), heart rate and O2 saturation.
Time frame: 2 hours
The investigators aimed to record the systemic side effects of combined nebulization of ketamine and lidocaine especially regarding heamodynamic stability (measurement of blood pressure) just after giving the nebulization and over 2 hours.
Time frame: 2 hours
The investigators aimed to measure the efficacy of combined lidocaine and ketamine vs. lidocaine alone as premedication of FOB regarding suppressing cough during the procedure using the cough score. The cough score, a simple assessment tool based on patient experience, was used to grade airway irritation from 0 (none) to 4 (severe).
Time frame: 2 hours
After use of the medications, local side effects were records and assessed using the verbal rating scale (VRS), a method for assessing pain, in which patients were asked to describe their pain on a scale from 0 (none) to 3 (severe).
Time frame: 2 hours
The investigators aimed to meaure the sedative effect of ketamine given by nebulization before FOB (secondary to systemic absoption) by Ramsay Sedation Scale, a tool used to assess a patient's level of sedation by observing the patient's behaviour and testing responsiveness during the procedure. The scale is ranging from 1 (anxious) to 6 (no response).
Time frame: 2 hours
The investigators aimed to record the patient comfort during the procedure using the patient satisfaction index through collecting patient feedback after the procedure through a questionnaire. The responses were scored from 1 (best) to 4 (worse).
Time frame: 2 hours
The patient tolerance during FOB was measured using 11-point numeric rating scale (NRS) ranging from 0 (completely satisfied) to 10 (completely dissatisfied).
Alexandria University
Other
Nebulized Lidocaine And Ketamine As Premedication Before Fiberoptic Bronchoscopy: A Case-Control Study
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