Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters

Patrocinadores

Patrocinador principal: Research Associates of New York, LLP

Fuente Research Associates of New York, LLP
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio March 2008
Fecha de Terminación September 2008
Fecha de finalización primaria August 2008
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
A change in mean arterial pressure (MAP) of 20% or more from baseline during upper endoscopy
Resultado secundario
Medida Periodo de tiempo
Episodes of bradycardia - pulse less than 50 during upper endoscopy
ECG changes consistent with myocardial ischemia during upper endoscopy
Decrease in respiratory rate - change of 20% or more from baseline 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. after all patients completed
Compare the level of sedation between the obese and non-obese cohorts after all patients completed
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts after all patients completed
Compare time to sedation in the obese and non-obese cohorts after all patients completed
Oxygen desaturation during upper endoscopy
Apneic episodes during upper endoscopy
Inscripción 65
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Lawrence B Cohen, MD Principal Investigator Research Associates of New York
Ubicación
Instalaciones: Research Associates of New York
Ubicacion Paises

United States

Fecha de verificación

October 2008

Fiesta responsable

Nombre Titulo: Lawrence B. Cohen, MD

Organización: Research Associates Of New York

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: obese subjects

Descripción: BMI > 35

Información de diseño del estudio

Modelo de observación: Case Control

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov