Reduction of Conscious Sedation Requirements by Olfactory Stimulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Reduction of Conscious Sedation Requirements by Olfactory Stimulation|
- Dose of narcotics per kg body weight
- BIS Scores
- Recovery Time [ Time Frame: minutes ]
- operative time [ Time Frame: minutes ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417001
|United States, Virginia|
|Naval Medical Center Department of Surgery|
|Portsmouth, Virginia, United States, 23708|
|Principal Investigator:||Paul A Lucha, DO||Naval Medical Center Department of Surgery- Portsmouth, VA|