Morbid Obesity Clinical Trial
— CerOxygenOfficial title:
Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients Undergoing Sleeve Gastrectomy: Prospective, Randomized Clinical Trial
Verified date | April 2018 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obesity is a chronic disease that affects quality and duration of life negatively. It's not clearly known the effects of low flow anesthesia on cerebral oxygenation with high-risk morbidly obese patients. In this study, it was aimed to compare the effects of general anesthesia with low flow (0,75 L/min) and normal flow (1,5 L/min) on cerebral oxygenation and depth of anesthesia in morbidly obese patients in bariatric surgery.
Status | Completed |
Enrollment | 52 |
Est. completion date | February 17, 2018 |
Est. primary completion date | January 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiology score I-III, - 18-65 years, - BMI> 35 Exclusion Criteria: - American Society of Anesthesiology IV, - Under 18 years, - Over 65 years, - Obstetric patients, - Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease, - Cerebrovascular disease, - Patients who refused informed consent forms |
Country | Name | City | State |
---|---|---|---|
Turkey | Sedat AKBAS | Malatya | Türkiye-Türkçe |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Turkey,
Jones KB Jr. Experience with the Roux-en-Y gastric bypass, and commentary on current trends. Obes Surg. 2000 Apr;10(2):183-5. Review. — View Citation
Kupisiak J, Goch R, Polenceusz W, Szyca R, Leksowski K. Bispectral index and cerebral oximetry in low-flow and high-flow rate anaesthesia during laparoscopic cholecystectomy - a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2011 Dec;6(4) — View Citation
Végh T. Cerebral Oximetry in General Anaesthesia. Turk J Anaesthesiol Reanim. 2016 Oct;44(5):247-249. Epub 2016 Oct 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regional Cerebral Oxygen Saturations (Left and Right) | The measurement of Regional Cerebral Oxygen Saturations by cerebral oximetry method which estimates regional tissue oxygenation by transcutaneous measurement on the frontal cortex. Cerebral oximeter (or named as NIRS, Near-infrared spectroscopy) is a monitor used following the adequacy of cerebral perfusion with noninvasive and continuous measurement and reflects regional saturation | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours | |
Secondary | Heart rate | Heart rate (beat/min) | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours | |
Secondary | Systolic and Diastolic Arterial Pressure (both) | Systolic and Diastolic Arterial Pressure (both) (mmHg) | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours | |
Secondary | End-tidal carbon dioxide (EtCO2) | EtCO2 is the measurement of the exhaled CO2 by capnography. This value is expressed in millimeters of mercury (mmHg) of CO2. | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours | |
Secondary | Bispectral Index (BIS) | Bispectral Index is a method for depth of anesthesia and assessment of sedation. The values of BIS decreases with the deepening of anesthesia. The values of 40-60 characterize the appropriate depth of anesthesia. | From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours |
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