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Sponsored by: |
United States Naval Medical Center, Portsmouth |
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Information provided by: | United States Naval Medical Center, Portsmouth |
ClinicalTrials.gov Identifier: | NCT00417001 |
Colonoscopy for investigation of lower gastrointestinal complaints or for colon cancer screening is one of the more frequent procedures performed by the Divisions of General Surgery and Gastroenterology. Traditionally, this has been performed while under conscious sedation (medication induced) which may improve patient acceptance and tolerance of the procedure but adds to the operative risk of the procedure. We propose a randomized prospective blinded trial to assess the utility of adding pleasing olfactory stimulation to the inhaled oxygen during the conscious sedation for colonoscopy in an effort to reduce the total doses of sedatives required while maintaining a similar level of sedation. This may decrease the overall period of recovery for the patient, increase the number of procedures which may be accomplished, and decrease the potential complications related to conscious sedation.
Condition | Intervention |
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Colon Cancer Health Screening Colon Polyps |
Procedure: Aroma therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reduction of Conscious Sedation Requirements by Olfactory Stimulation |
Estimated Enrollment: | 284 |
Study Start Date: | October 2006 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul A Lucha, DO | 757-953-2464 | paul.lucha@med.navy.mil |
Contact: Krista Puttler, MD | 757-953-2464 | Krista.Puttler@med.navy.mil |
United States, Virginia | |
Naval Medical Center Department of Surgery | Recruiting |
Portsmouth, Virginia, United States, 23708 | |
Contact: Paul A Lucha, DO 757-953-2464 paul.lucha@med.navy.mil | |
Contact: Krista Puttler, MD 757-953-2464 krista.puttler@med.navy.mil | |
Principal Investigator: Paul A Lucha, DO |
Principal Investigator: | Paul A Lucha, DO | Naval Medical Center Department of Surgery- Portsmouth, VA |
Study ID Numbers: | P05-075 |
Study First Received: | December 27, 2006 |
Last Updated: | December 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00417001 |
Health Authority: | United States: Federal Government |
sedation colonoscopy Aroma therapy |
Pathological Conditions, Anatomical Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Colonic Polyps |
Gastrointestinal Neoplasms Polyps Intestinal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Intestinal Polyps |