Reduction of Conscious Sedation Requirements by Olfactory Stimulation

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00417001
First received: December 27, 2006
Last updated: January 20, 2009
Last verified: January 2009
  Purpose

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. The investigators 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
Colon Cancer Screening
Colon Polyps
Procedure: Aroma therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • Dose of narcotics per kg body weight

Secondary Outcome Measures:
  • BIS Scores
  • Recovery Time [ Time Frame: minutes ]
  • operative time [ Time Frame: minutes ]

Estimated Enrollment: 284
Study Start Date: October 2006
Study Completion Date: October 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417001

Locations
United States, Virginia
Naval Medical Center Department of Surgery
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Paul A Lucha, DO Naval Medical Center Department of Surgery- Portsmouth, VA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00417001     History of Changes
Other Study ID Numbers: P05-075
Study First Received: December 27, 2006
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, Portsmouth:
sedation
colonoscopy
Aroma therapy

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014