Nebulized Lidocaine And Ketamine As Premedication Before Fiberoptic Bronchoscopy: A Case-Control Study
| Registry | NCT07743333 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 134 (Actual) |
| Sponsor | Alexandria University (Other) |
| Conditions | Fiberoptic Bronchoscopy (FOB), Lung Cancer (Diagnosis), Premedication |
| Interventions | Nebulized lidocaine and ketamine, Nebulized Lidocaine, Lidocaine spray (2%) (Drug) |
| Dates | start 2024-09-01, primary completion 2025-02-28, completion 2025-02-28, first posted 2026-08-03, last updated 2026-08-03 |
| Locations | 1 site in Egypt |
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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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| interventional A Group | Active comparator | Drug: Nebulized lidocaine and ketamine | This group of patient were given nebulized lidacaine and ketamine before FOB. |
| Interventional B Group | Active comparator | Drug: Nebulized Lidocaine | This group of patient were given nebulized lidacaine only before FOB. |
| Control group | Placebo comparator | Drug: Lidocaine spray (2%) | This group of patient were given lidacaine spray to the oral and nasal cavity before FOB. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Alexandria University Faculty of Medicine | Alexandria, Alexandria Governorate | Egypt |