Morbid ObesityCerOxygenNCT03438734
Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients
A study testing Regional cerebral oxygen saturation and Bispectral Index (BIS) in people with Morbid Obesity and Anesthesia Awareness, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Anesthesia Awareness, Anesthesia Complication
- What is being tested?
- Regional cerebral oxygen saturation and Bispectral Index (BIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2017to 17 Feb 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology score I-III,
- 18-65 years,
- BMI> 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Regional cerebral oxygen saturation, Bispectral Index (BIS)
- Keywords
- Bariatric surgery, Low flow anesthesia, Bispectral index, Regional cerebral oximetry
- Medical subject headings
- Obesity, Morbid, Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional cerebral oxygen saturationDevice
Also called NIRS (Near-infrared spectroscopy system)
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.
Bispectral Index (BIS)Device
Also called BIS
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.
| Study group | Role | What they receive |
|---|---|---|
| Low flow | Active comparator | 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. Receives: Device: Regional cerebral oxygen saturation; Device: Bispectral Index (BIS) |
| Normal flow | Sham comparator | 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. Receives: Device: Regional cerebral oxygen saturation; Device: Bispectral Index (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Secondary outcomes (4)
Heart rate
Heart rate (beat/min)
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Systolic and Diastolic Arterial Pressure (both)
Systolic and Diastolic Arterial Pressure (both) (mmHg)
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
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.
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
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.
Measured: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start8 Nov 2017
- Primary completion17 Jan 2018
- Study completion17 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective Randomized Clinical Study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat AKBAS, Inonu University
- Investigators
- Sedat AKBAS, Study director, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438734
- Sponsor's protocol ID
- sedatakbas1
- Acronym
- CerOxygen
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10782184Vegh 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.
PubMed 27909605Kupisiak 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.
PubMed 23255984
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03438734
- Acronym / sponsor ID
- CerOxygen / sedatakbas1
- Keywords
- Bariatric surgery, Low flow anesthesia, Bispectral index, Regional cerebral oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Low flow | Active comparator | Device: Regional cerebral oxygen saturation, Device: Bispectral Index (BIS)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. |
| Normal flow | Sham comparator | Device: Regional cerebral oxygen saturation, Device: Bispectral Index (BIS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology score I-III,
- 18-65 years,
- BMI> 35
Key exclusion criteria (7 listed)
- American Society of Anesthesiology IV,
- Under 18 years,
- Over 65 years,
- Obstetric patients,
- Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional cerebral oxygen saturationAlso: NIRS (Near-infrared spectroscopy system)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. | Device | Low flow, Normal flow |
| Bispectral Index (BIS)Also: BISThe 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. | Device | Low flow, Normal flow |
Primary outcome
Regional Cerebral Oxygen Saturations (Left and Right)
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
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
4 secondary outcomes
Heart rate
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Systolic and Diastolic Arterial Pressure (both)
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
End-tidal carbon dioxide (EtCO2)
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Bispectral Index (BIS)
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
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 17 Apr 2018.
- Background: PubMed 10782184Jones 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.
- Background: PubMed 27909605Vegh 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 publication: PubMed 23255984Kupisiak 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.
- Individual participant dataSharing planned: No
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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.
Sedat AKBAS study director
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional cerebral oxygen saturation and Bispectral Index (BIS) in people with Morbid Obesity and Anesthesia Awareness, run by Inonu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 17 Apr 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Regional Cerebral Oxygen Saturations (Left and Right) (time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438734, which also lists 3 linked publications.
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 17 Apr 2018.