Colon Cancer ScreeningNCT00417001
Reduction of Conscious Sedation Requirements by Olfactory Stimulation
A study testing Aroma therapy in people with Colon Cancer Screening and Colon Polyps, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening, Colon Polyps
- What is being tested?
- Aroma therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's presenting for colon cancer screening, colon cancer follow up colonoscopy, or polyp follow up colonoscopy
Who cannot join
- Allergy to Demerol or Versed, symptomatic colon disease, allergy to a component in the aroma
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Department of Surgery
Portsmouth, Virginia, 23708
About this study
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.
Read the detailed description
- 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.
- Conditions
- Colon Cancer Screening, Colon Polyps
- Being tested
- Aroma therapy
- Keywords
- sedation, colonoscopy, Aroma therapy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroma therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2008
- Study completionOct 2008
Why it stopped: unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul A Lucha, DO, Principal investigator, Naval Medical Center Department of Surgery- Portsmouth, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417001
- Sponsor's protocol ID
- P05-075
- Status last verified
- Aug 2025
- First submitted
- 27 Dec 2006
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Conscious Sedation Requirements by Olfactory Stimulation
- ClinicalTrials.gov ID
- NCT00417001
- Acronym / sponsor ID
- P05-075
- Conditions
- Colon Cancer Screening, Colon Polyps
- Keywords
- sedation, colonoscopy, Aroma therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Oct 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient's presenting for colon cancer screening, colon cancer follow up colonoscopy, or polyp follow up colonoscopy
Key exclusion criteria (1 listed)
- Allergy to Demerol or Versed, symptomatic colon disease, allergy to a component in the aroma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aroma therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Lucha, DO principal investigator
Naval Medical Center Department of Surgery- Portsmouth, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aroma therapy in people with Colon Cancer Screening and Colon Polyps, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.