Fiberoptic Bronchoscopy (FOB), Lung Cancer (Diagnosis), Premedication
Conditions
Keywords
Nebulized Lidocaine, Nebulized Ketamine
Brief summary
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.
Detailed description
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).
Interventions
DRUGNebulized lidocaine and ketamine
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.
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
The current study has 3 groups of patients subjected to 3 different methods and drugs before bronchoscopy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients were assigned for FOB for diagnostic causes as part of their usual care. * All patients were assigned for FOB for therapeutic causes as part of their usual care.
Exclusion criteria
* unstable angina or recent myocardial infarction, * hypoxemia that is not corrected by oxygen therapy, * increased intracranial pressure or recent cerebrovascular stroke, * uncontrolled uraemia, * uncontrolled hypertension, * current viral infections or colds, * history of allergy to lidocaine or ketamine, * altered mental status, or * non-corrected coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of adding ketamine to lidocaine | 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. |
| Efficacy of nebulized ketamine to lidocaine | 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). |
| Local complication of ketamine and lidocaine | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation effect of nebulized ketamine | 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). |
| Comfort of the patient during FOB | 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). |
| Patient tolerance during FOB | 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). |
Countries
Egypt
Outcome results
None listed