Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients
This study has been completed.
Sponsor:
Research Associates of New York, LLP
Information provided by:
Research Associates of New York, LLP
ClinicalTrials.gov Identifier:
NCT00782873
First received: October 29, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters |
Resource links provided by NLM:
Further study details as provided by Research Associates of New York, LLP:
Primary Outcome Measures:
- A change in mean arterial pressure (MAP) of 20% or more from baseline [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Episodes of bradycardia - pulse less than 50 [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
- ECG changes consistent with myocardial ischemia [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
- Decrease in respiratory rate - change of 20% or more from baseline [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Compare the level of sedation between the obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
- compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
- Compare time to sedation in the obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
- Oxygen desaturation [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
- Apneic episodes [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
| Enrollment: | 65 |
| Study Start Date: | March 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
obese subjects
BMI > 35
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The research subjects will be selected from a private practice.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782873
Locations
| United States, New York | |
| Research Associates of New York | |
| New York, New York, United States, 10075 | |
Sponsors and Collaborators
Research Associates of New York, LLP
Investigators
| Principal Investigator: | Lawrence B Cohen, MD | Research Associates of New York |
More Information
No publications provided
| Responsible Party: | Lawrence B. Cohen, MD, Research Associates Of New York |
| ClinicalTrials.gov Identifier: | NCT00782873 History of Changes |
| Other Study ID Numbers: | 424-02-08 |
| Study First Received: | October 29, 2008 |
| Last Updated: | October 29, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Research Associates of New York, LLP:
|
propofol sedation safety obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Propofol Anesthetics, Intravenous |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 23, 2013