An interventional study of Regional cerebral oxygen saturation and Bispectral Index (BIS) in Morbid Obesity, Anesthesia Awareness and Anesthesia Complication, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Inonu University · Not applicable, Interventional, and Screening
Among 70 studies in Obesity, Morbid with a site in Turkey — 8 open to participants now, 8 under way, 1 of them phase 3. Obesity, Morbid · Turkey.
Among the 70 studies in Obesity, Morbid with a site in Turkey, this one is the 26th largest by enrollment of the 38 interventional ones that give a count, is one of 3 that started in 2017, is one of 33 with no phase, and was the 12th registered.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
Browse Obesity, Morbid studies →8 of the 70 studies in Obesity, Morbid with a site in Turkey are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in Turkey, Germany
Ages 2+
Kocaeli University · Sites in Turkey
Ages 18–80 · Men only
Harran University · Sites in Turkey
Ages 18–65 · Healthy volunteers
Başakşehir Çam & Sakura City Hospital · Sites in Turkey
Ages 18–65
Gazi University · Sites in Turkey
Ages 18+
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 109 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 83 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
70 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Median enrollment 66 across the 38 interventional studies, 68 across the 32 observational. Of the 52 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 70 have an industry lead sponsor. The 10 most frequent:
Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.
Inonu University has 9 studies filed under Obesity, Morbid — fewer than ten, so there is no comparison to draw.
4 of the studies in Obesity, Morbid with a site in Turkey that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07220772Phase 3Regeneron PharmaceuticalsA Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults | 2027-06-18 |
| NCT07643376Toros UniversityEvaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management | 2027-01-01 |
| NCT07668765Gazi UniversityGLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity | 2027-04 |
| NCT05927519Kocaeli UniversityComparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study | 2027-10-05 |
Among the 70 studies in Obesity, Morbid with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Device: Regional cerebral oxygen saturation · Device: Bispectral Index (BIS)
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.
Also known as: NIRS (Near-infrared spectroscopy system)
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.
Also known as: BIS
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
Time frame: From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours
Heart rate
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
Systolic and Diastolic Arterial Pressure (both)
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
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.
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)
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Jan 2018, 2 months.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 2 months is below that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.