Trial Information

Reduction of Conscious Sedation Requirements by Olfactory Stimulation

4. RESEARCH DESIGN/METHODS/SUBJECT JUSTIFICATION

1. 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.

1. 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.

2. 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.

3. Randomization Procedures A computer generated block randomized schedule will be
used. The patients will be randomized the day of the procedure.

2. 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.