ObesityNCT00782873
Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients
An observational study of Obesity, run by Research Associates of New York, LLP at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2008
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research subjects will be selected from a private practice.
Who may be able to join
- Undergoing an endoscopic esophagostroduodenoscopy (EGD)
- Capable of providing written informed consent and willing and able to comply with all procedures of the study
- Adults between the ages of 18 and 85 inclusive (and of legal age to consent)
- ASA score of I, II, or III
Who cannot join
- Severe acute illness that is not resolved or stabilized prior to enrollment. Study entry will be based on the investigator's judgment
- Need for sleep or narcotic analgesic medication on a continuous basis during the proceeding 6 months
- Pregnancy
- A history of drug addiction or alcohol abuse within the past 12 months. Alcohol can be consumed in moderation. The consumption of alcohol should be within the routine pattern for the individual before the study.
- A history of seizure disorder.
- Allergy to propofol, soy beans, or eggs.
- Prior history of difficult intubation.
- Prior history of severe complications during conscious sedation. Study entry will be based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Associates of New York
New York, New York, 10075
About this study
Official title: Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters
The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy.
The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.
Read the detailed description
The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. We will use changes in pulmonary and hemodynamic parameters as the primary safety measure in this study. We will compare these results in 30 non-obese patients and in 30 obese patients.
The term balanced propofol sedation refers to using a low dose of propofol in combination with small amounts of an opioid and midazolam.
- Conditions
- Obesity
- Keywords
- propofol, sedation, safety, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese subjects | BMI > 35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in mean arterial pressure (MAP) of 20% or more from baseline
Measured: during upper endoscopy
Secondary outcomes (9)
Episodes of bradycardia - pulse less than 50
Measured: during upper endoscopy
ECG changes consistent with myocardial ischemia
Measured: during upper endoscopy
Decrease in respiratory rate - change of 20% or more from baseline
Measured: during upper endoscopy
Assess the dose of propofol, midazolam, and fentanyl necessary to achieve adequate sedation during upper endoscopy and compare the dose requirements of the obese and non-obese patient cohorts.
Measured: after all patients completed
Compare the level of sedation between the obese and non-obese cohorts
Measured: after all patients completed
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts
Measured: after all patients completed
Compare time to sedation in the obese and non-obese cohorts
Measured: after all patients completed
Oxygen desaturation
Measured: during upper endoscopy
Apneic episodes
Measured: during upper endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Associates of New York, LLP
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence B Cohen, MD, Principal investigator, Research Associates of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782873
- Sponsor's protocol ID
- 424-02-08
- Status last verified
- Oct 2008
- First submitted
- 29 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters
- ClinicalTrials.gov ID
- NCT00782873
- Acronym / sponsor ID
- 424-02-08
- Conditions
- Obesity
- Keywords
- propofol, sedation, safety, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Research Associates of New York, LLPUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 31 Oct 2008 (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.
The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy.
The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.
Detailed description
The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. We will use changes in pulmonary and hemodynamic parameters as the primary safety measure in this study. We will compare these results in 30 non-obese patients and in 30 obese patients.
The term balanced propofol sedation refers to using a low dose of propofol in combination with small amounts of an opioid and midazolam.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese subjects | – | –BMI > 35 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research subjects will be selected from a private practice.
Key inclusion criteria (4 listed)
- Undergoing an endoscopic esophagostroduodenoscopy (EGD)
- Capable of providing written informed consent and willing and able to comply with all procedures of the study
- Adults between the ages of 18 and 85 inclusive (and of legal age to consent)
- ASA score of I, II, or III
Key exclusion criteria (8 listed)
- Severe acute illness that is not resolved or stabilized prior to enrollment. Study entry will be based on the investigator's judgment
- Need for sleep or narcotic analgesic medication on a continuous basis during the proceeding 6 months
- Pregnancy
- A history of drug addiction or alcohol abuse within the past 12 months. Alcohol can be consumed in moderation. The consumption of alcohol should be within the routine pattern for the individual before the study.
- A history of seizure disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A change in mean arterial pressure (MAP) of 20% or more from baseline
Time frame: during upper endoscopy
9 secondary outcomes
Episodes of bradycardia - pulse less than 50
Time frame: during upper endoscopy
ECG changes consistent with myocardial ischemia
Time frame: during upper endoscopy
Decrease in respiratory rate - change of 20% or more from baseline
Time frame: during upper endoscopy
Assess the dose of propofol, midazolam, and fentanyl necessary to achieve adequate sedation during upper endoscopy and compare the dose requirements of the obese and non-obese patient cohorts.
Time frame: after all patients completed
Compare the level of sedation between the obese and non-obese cohorts
Time frame: after all patients completed
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts
Time frame: after all patients completed
Compare time to sedation in the obese and non-obese cohorts
Time frame: after all patients completed
Oxygen desaturation
Time frame: during upper endoscopy
Apneic episodes
Time frame: during upper endoscopy
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 31 Oct 2008.
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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.
Lawrence B Cohen, MD principal investigator
Research Associates of New York
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 Obesity, run by Research Associates of New York, LLP 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 4 inclusion and 8 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 31 Oct 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.
What does the primary outcome measure?
A change in mean arterial pressure (MAP) of 20% or more from baseline (time frame: during upper endoscopy). It is what the study was designed to measure, not a finding.
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 31 Oct 2008.