Sedation for Non-Emergent Upper and/or Lower EndoscopyNCT00559260
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices
An observational study of Sedation for Non-Emergent Upper and/or Lower Endoscopy, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation for Non-Emergent Upper and/or Lower Endoscopy
- What is being tested?
- Passive monitoring with pulse-oximetry, NIBP and ECG
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to not given
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy
Who cannot join
- Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis)
- Baseline respiratory rate of < 6 breaths per minute
- Baseline hypotension (systolic blood pressure < 90 mm Hg)
- Baseline arterial oxygen saturation < 90% on room air
- Baseline bradycardia: heart rate < 50 beats per minute
- Baseline tachycardia: heart rate > 110 beats per minute
Show all 11Show fewer
- Allergy or inability to tolerate any of the sedatives or analgesics to be administered during the procedure
- Inability to squeeze the Automated Responsiveness Test hand piece (last 50 subjects only)
- Significant hearing impairment
- Actively abusing alcohol, opioids, benzodiazapines or sedatives, or other drugs
- Are considered tolerant to opioids, benzodiazapines and/or other sedatives through prescription.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma
About this study
Official title: Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices While Being Passively Monitored
This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.
- Being tested
- Passive monitoring with pulse-oximetry, NIBP and ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive monitoring with pulse-oximetry, NIBP and ECGDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation for Non-Emergent Upper and/or Lower EndoscopyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Miner, MD, Principal investigator, Oklahoma Foundation for Digestive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559260
- Sponsor's protocol ID
- CI-02-0004
- Status last verified
- Sep 2008
- First submitted
- 15 Nov 2007
- Last updated
- 15 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices While Being Passively Monitored
- ClinicalTrials.gov ID
- NCT00559260
- Acronym / sponsor ID
- CI-02-0004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- First posted
- 16 Nov 2007 (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.
This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy
Key exclusion criteria (11 listed)
- Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis)
- Baseline respiratory rate of < 6 breaths per minute
- Baseline hypotension (systolic blood pressure < 90 mm Hg)
- Baseline arterial oxygen saturation < 90% on room air
- Baseline bradycardia: heart rate < 50 beats per minute
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 |
|---|---|---|
| Passive monitoring with pulse-oximetry, NIBP and ECG | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
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.
Philip Miner, MD principal investigator
Oklahoma Foundation for Digestive Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation for Non-Emergent Upper and/or Lower Endoscopy, run by Ethicon Endo-Surgery 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 11 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: finished, as of the sponsor's last update on 15 Sep 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 15 Sep 2008.