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Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients (CerOxygen)

Primary Purpose

Morbid Obesity, Anesthesia Awareness, Anesthesia Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Regional cerebral oxygen saturation
Bispectral Index (BIS)
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Morbid Obesity focused on measuring Bariatric surgery, Low flow anesthesia, Bispectral index, Regional cerebral oximetry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sedat AKBAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low flow

Normal flow

Arm Description

Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 0.75 L/min. Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.

Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 1.5 L/min.Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
Heart rate (beat/min)
Systolic and Diastolic Arterial Pressure (both)
Systolic and Diastolic Arterial Pressure (both) (mmHg)
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.
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.

Full Information

First Posted
February 6, 2018
Last Updated
April 13, 2018
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03438734
Brief Title
Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients
Acronym
CerOxygen
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
February 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Obesity is a chronic disease that affects quality and duration of life negatively. It is one of the most important health problem in the world along with very common in Turkey. Initially, obesity was considered the problem of developed countries but it has become inevitable with increase income levels, changes in lifestyles, reduction of energy consumption and increase of energy intake in developing countries. Today, the second important cause of preventable deaths after smoking is obesity. The World Health Organization (WHO) has stated that it will be the most important health problem of the 21st century. According to WHO determinations; as of 2008, the prevalence of overweight in the world is 35% and the prevalence of obesity is around 11%. The definition of body mass index (BMI) is used in defining and classifying obesity. WHO is making the definition of overweight and obesity based on body mass index [BMI = Weight (kg) / Height (m2)]. It is called as obesity when the calculated value is over 30 kg/m2, morbid obesity over 40 kg/m2 and super obesity over 50 kg/m2. Morbid obesity operations, with effective results on achieving weight loss continuity once it has been widely applied in Europe and the United States, have been frequently implemented in Turkey as well. With the rising obesity in Turkey, laparoscopic bariatric surgery which has low complication rates is preferred. Low flow general anesthesia is applied to reduce pollution rates and treatment costs in operation rooms. However, the reduction of fresh gas flow should not affect the quality and safety of anesthesia management, especially in high risk operations such as morbid obesity surgery. Insufflation of abdominal cavity with carbon dioxide during laparoscopic surgery is resulted in increased intraabdominal pressure, decreased functional residual capacity and pulmonary compliance, increased hypercapnia and systemic vascular resistance. Especially in the trendelenburg position it may be difficult to detect cerebral hypoxia as a consequence of increased intracranial pressure and decreased cerebral blood flow . During general anesthesia, there are several options for monitoring the cerebral condition. One of them is cerebral oximetry method which estimates regional tissue oxygenation by transcutaneous measurement on the frontal cortex. Near-infrared spectroscopy (NIRS) is a monitor used following the adequacy of cerebral perfusion with noninvasive and continuous measurement and reflects regional saturation. With the development of technology, the safety of anesthesia devices and the advancement of monitoring techniques are positively affecting the anesthesia management. The effects of low flow anesthesia, which has been used for years and whose positive aspects are well practiced, are not clearly known on cerebral oxygenation with high-risk morbidly obese patients. In this prospective randomized 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Anesthesia Awareness, Anesthesia Complication
Keywords
Bariatric surgery, Low flow anesthesia, Bispectral index, Regional cerebral oximetry

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective Randomized Clinical Study
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low flow
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 0.75 L/min. Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.
Arm Title
Normal flow
Arm Type
Sham Comparator
Arm Description
Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 1.5 L/min.Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.
Intervention Type
Device
Intervention Name(s)
Regional cerebral oxygen saturation
Other Intervention Name(s)
NIRS (Near-infrared spectroscopy system)
Intervention Description
Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients.
Intervention Type
Device
Intervention Name(s)
Bispectral Index (BIS)
Other Intervention Name(s)
BIS
Intervention Description
The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of BIS decreases with the deepening of anesthesia.
Primary Outcome Measure Information:
Title
Regional Cerebral Oxygen Saturations (Left and Right)
Description
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
Time Frame
From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate (beat/min)
Time Frame
From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Title
Systolic and Diastolic Arterial Pressure (both)
Description
Systolic and Diastolic Arterial Pressure (both) (mmHg)
Time Frame
From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Title
End-tidal carbon dioxide (EtCO2)
Description
EtCO2 is the measurement of the exhaled CO2 by capnography. This value is expressed in millimeters of mercury (mmHg) of CO2.
Time Frame
From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Title
Bispectral Index (BIS)
Description
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.
Time Frame
From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18-65 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedat AKBAS
Organizational Affiliation
Inonu University Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Sedat AKBAS
City
Malatya
State/Province
Türkiye-Türkçe
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10782184
Citation
Jones KB Jr. Experience with the Roux-en-Y gastric bypass, and commentary on current trends. Obes Surg. 2000 Apr;10(2):183-5. doi: 10.1381/096089200321668659. No abstract available.
Results Reference
background
PubMed Identifier
27909605
Citation
Vegh T. Cerebral Oximetry in General Anaesthesia. Turk J Anaesthesiol Reanim. 2016 Oct;44(5):247-249. doi: 10.5152/TJAR.2016.26092016. Epub 2016 Oct 1. No abstract available.
Results Reference
background
PubMed Identifier
23255984
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):226-30. doi: 10.5114/wiitm.2011.26256. Epub 2011 Dec 20.
Results Reference
result
Links:
URL
http://www.temd.org.tr/files/file/OBEZITE_TTK_web.pdf
Description
Turkey Endocrinology and Metabolism Society of Obesity Diagnosis and Treatment Guide. Obesity, Dyslipidemia, Hypertension Working Group, 2014; 1: 11-5.

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Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients

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