Nebulized Lidocaine And Ketamine As Premedication Before Fiberoptic Bronchoscopy: A Case-Control Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Safety of adding ketamine to lidocaine
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Safety of adding ketamine to lidocaine
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.
Efficacy of nebulized ketamine to lidocaine
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).
Local complication of ketamine and lidocaine
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).
Secondary Outcomes
- Sedation effect of nebulized ketamine(2 hours)
- Comfort of the patient during FOB(2 hours)
- Patient tolerance during FOB(2 hours)
Investigators
Hanaa Shafiek
Professor Doctor
Alexandria University