- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417001
Reduction of Conscious Sedation Requirements by Olfactory Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
4. RESEARCH DESIGN/METHODS/SUBJECT JUSTIFICATION
General Approach Two hundred and eighty four patients presenting to the endoscopy clinic will be offered participation in the study. They will be randomized to either 1 ml of sterile water or 1 ml of cherry scented flavoring (Lorann Oils Inc, Lansing MI) (identical oil used by our pediatric anesthesiologists for scenting the anesthesia mask during the induction phase of general anesthesia). These will be connected to the inline oxygen tubing via an Leukens trap with oxygen flowing at 4 liters/ minute rate and titrated to maintain a pulse oximetry saturation level of over 90%. The water or flavoring will not be nebulized into the oxygen. The oxygen will pass through the inactive Leukens trap container and pick up whatever aroma is present. A BIS monitor (Aspect Medical Systems Newton MA) will be applied. Data will be recorded at 5 minute intervals (BIS scores). The BIS score will not be used to titrate the sedative medications since the literature is controversial as to whether a given BIS score is consistently considered adequate sedation. Total recovery time (post procedure), BIS scores, and sedative doses will be recorded.
- Research Objective To determine if the addition of pleasing olfactory stimulation can reduce the total dose required for sedatives, decrease the recovery time required but maintain the same levels of sedation.
- Detail how many groups or arms are in the study and what each receives ' Two groups will be used. One will receive inhalation of cherry flavored essential oil and the other sterile water.
- Randomization Procedures A computer generated block randomized schedule will be used. The patients will be randomized the day of the procedure.
- Methods and Materials Two hundred and eighty four consecutive patients presenting for elective colonoscopy with endoscopist provided sedation (ASA 1 and 2 per NMCP policy) will be offered participation in the trial. They will be consented the day of the procedure by one of the subinvestigators and randomized to either receive olfactory stimulation by cherry flavored oil (via in line aerosol chamber similar to nebulizer treatments) or sterile water. A standard volume of 1 ml will be placed in the chamber without additional water. A BIS monitor will be placed and BIS scores recorded at time zero (prior to sedation) and every 5 minutes during the procedure. The BIS score will not be used to titrate sedation rather the clinical parameters used by the endoscopist will be used (pulse oximetry, blood pressure, heart rate, clinical level of arousal) because it is controversial in the literature using BIS scores to titrate conscious sedation. The BIS scores will provide an additional rough estimate as to the equivalence of levels of sedation during the procedure. Total doses of medications, BIS scores, procedure duration, and recovery duration will be recorded.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Portsmouth, Virginia, United States, 23708
- Naval Medical Center Department of Surgery
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient's presenting for colon cancer screening, colon cancer follow up colonoscopy, or polyp follow up colonoscopy
Exclusion Criteria:
- Allergy to Demerol or Versed, symptomatic colon disease, allergy to a component in the aroma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Dose of narcotics per kg body weight
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BIS Scores
|
|
Recovery Time
Time Frame: minutes
|
minutes
|
operative time
Time Frame: minutes
|
minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul A Lucha, DO, Naval Medical Center Department of Surgery- Portsmouth, VA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05-075
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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