Comparison of Propofol/Alfentanil With Propofol/Ketamine (KET-001)

November 26, 2013 updated by: Mordechai Kremer, Rabin Medical Center

Safety and Efficacy of Sedation for Flexible Fiberoptic Bronchoscopy: Comparison of Propofol/Alfentanil With Propofol/Ketamine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.

Patients whose functional oxygen saturation (SpO2) prior to the beginning of the procedure will be lower than 92% while connected to a nasal cannula, will receive oxygen supplementation via a face mask.

If the SpO2 after initiation of sedation will fall below 90%, the patients' airways will be opened using a jaw-thrust maneuver or insertion of a nasal airway. Should the SpO2 remain low, the patient will receive oxygen supplementation via a face-mask.

If deemed necessary, additional safety measures will be taken by the anesthesiologist or by the performer of the bronchoscopy, such as administration of oxygen directly through the bronchoscope, assisted ventilation with an Ambu bag, and tracheal intubation.

The duration of bronchoscopy will be calculated from the administration of sedation until the flexible bronchoscope is removed from the tracheobronchial tree.

In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry, and transcutaneous carbon dioxide (PtCO2, using a digital sensor placed on the patient's earlobe),and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded beginning from prior to connecting the patient to the nasal cannula before initiation of sedation, throughout the entire procedure and until 10 minutes after removal of the bronchoscope from the nasopharynx.

Immediately after the end of the procedure, the bronchoscopist will grade the quality of sedation (ease of performing the procedure) by Visual Analog Scale.

A questionnaire evaluating pain and discomfort by Visual Analog Scale will be completed by the patient when fully awake after the procedure.(~30 minutes after the end of the procedure).

Percutaneous carbon dioxide tension, blood oxygenation, heart rate, and blood pressure will be compared between the groups.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petach Tikva, Israel, 49100
        • Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol + alfentanil

Patients from the Propofol / Alfentanil group will receive in addition:

  1. A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.
  2. Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required
Drug: Propofol
Other Names:
  • Diprivan
Drug: Alfentanil
Other Names:
  • Alfenta
Active Comparator: propofol + ketamine

Patients from the Propofol / Ketamine group will receive in addition:

  1. 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.
  2. Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.
Drug: Propofol
Other Names:
  • Diprivan
Drug: Ketamine
Other Names:
  • Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average expected time of 45 minutes
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.
Average expected time of 45 minutes.
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.
Average expected time of 45 minutes
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
Average expected time of 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen supplementation
Time Frame: Average expected time of 45 minutes

Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with a jaw thrust maneuver. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1.

The percentage of patients who needed supplemental oxygen will be evaluated
Average expected time of 45 minutes
Naso/oropharyngeal tube insertion
Time Frame: Average expected time of 45 minutes

Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with jaw support. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1

The percentage of patients who needed Naso/oropharyngeal tube insertion will be evaluated
Average expected time of 45 minutes
A questionnaire evaluating pain and discomfort
Time Frame: Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes)
A questionnaire evaluating pain and discomfort by Visual Analog Scale will be completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure)
Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes)
A questionnaire evaluating the quality of sedation
Time Frame: Immediately after end of procedure (average expected time of 30 minutes)
A questionnaire evaluating the quality of sedation and the ease of performing the procedure by Visual Analog Scale will be completed by the bronchoscopist immediately after the procedure.
Immediately after end of procedure (average expected time of 30 minutes)
Total propofol dosage
Time Frame: Average expected time of 30 minutes
The total amount of propofol used throughout the procedure will be calculated.
Average expected time of 30 minutes
Time to full awakening and orientation
Time Frame: Anticipated to be in the range of 1-30 minutes after the end of the procedure
Time from termination of the procedure to full awakening and orientation
Anticipated to be in the range of 1-30 minutes after the end of the procedure
Time to discharge
Time Frame: Average expected time of 60 minutes. Anticipated to be in the range of 45-120 minutes after the end of fiberoptic bronchoscopy
The time from the termination of the procedure until the patient is discharged from the recovery unit will be measured.
Average expected time of 60 minutes. Anticipated to be in the range of 45-120 minutes after the end of fiberoptic bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Study Director: Mordechai R Kramer, MD, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC13ctl

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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