Safety and Efficacy of Sedation for Flexible Fiberoptic Bronchoscopy: Comparison of Propofol/Alfentanil With Propofol/Ketamine
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Percutaneous carbon dioxide tension
Study Overview
Brief Summary
A prospective, randomized, patient-blinded comparison of the safety and efficacy of conscious sedation by propofol/alfentanil with propofol/ketamine in patients undergoing flexible fiberoptic bronchoscopy.
Detailed Description
The study group will include 80 patients undergoing flexible fiberoptic bronchoscopy(FFB).
Patients will be randomly assigned prior to the procedure to receive sedation by either propofol/alfentanil (PA group) or propofol/ketamine (PK group), using either the sealed envelope method or by computer randomization.
All patients will receive local anesthesia with Lidocaine 2% (total dose of 5-10 ml) that will be sprayed via the bronchoscope on the vocal cords before passage through them, as well as into the bronchial tree in order to suppress coughing.
In addition, patients from both groups will optionally receive intravenous Midazolam (up to a total dose of 0.05 mg/kg)if deemed necessary during the procedure.
Sedation will be started by 10-15 mcg/kg Alfentanil and 0.4 mg/kg Propofol, or by 0.2-0.3 mg/kg Ketamine and 0.4 mg/kg Propofol. It will be maintained by additional boluses of Propofol (aliquots of 10-50 mg) or by additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists grade I or II
- •patients that will be referred to the procedure for bronchoalveolar lavage and cytologic/bacteriologic sampling, endoluminal biopsies for pathologic /bacteriologic analysis, or for regaining patency (mechanically or laser-assisted) of airways that are obstructed by secretions, tumors or foreign bodies
Exclusion Criteria
- •patient refusal or inability to provide informed consent
- •American Society of Anesthesiologists grade III or higher
- •allergy to study medications
- •patients who have an endotracheal tube or tracheostomy
Arms & Interventions
propofol + alfentanil
Patients from the Propofol / Alfentanil group will receive in addition:
- A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
- Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required
Intervention: Propofol (Drug)
propofol + alfentanil
Patients from the Propofol / Alfentanil group will receive in addition:
- A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
- Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required
Intervention: Alfentanil (Drug)
propofol + ketamine
Patients from the Propofol / Ketamine group will receive in addition:
- A loading dose of 0.2-0.3 mg/kg Ketamine + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
- Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.
Intervention: Propofol (Drug)
propofol + ketamine
Patients from the Propofol / Ketamine group will receive in addition:
- A loading dose of 0.2-0.3 mg/kg Ketamine + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
- Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.
Intervention: Ketamine (Drug)
Outcomes
Primary Outcomes
Percutaneous carbon dioxide tension
Time Frame: Average expected time of 45 minutes
Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
oxygen saturation
Time Frame: Average expected time of 45 minutes.
Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
heart rate
Time Frame: Average expected time of 45 minutes
Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
Non-invasive blood pressure
Time Frame: Average expected time of 45 minutes
Every 5 minutes. Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination
Secondary Outcomes
- Oxygen supplementation(Average expected time of 45 minutes)
- Naso/oropharyngeal tube insertion(Average expected time of 45 minutes)
- A questionnaire evaluating pain and discomfort(Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes))
- A questionnaire evaluating the quality of sedation(Immediately after end of procedure (average expected time of 30 minutes))
- Total propofol dosage(Average expected time of 30 minutes)
- Time to full awakening and orientation(Anticipated to be in the range of 1-30 minutes after the end of the procedure)
- Time to discharge(Average expected time of 60 minutes. Anticipated to be in the range of 45-120 minutes after the end of fiberoptic bronchoscopy)
Investigators
Mordechai Kremer
Head of Pulmonary Institute
Rabin Medical Center