- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06636448
The Relationship Between Body Mass Index and Patient Outcomes in Low Flow Anaesthesia
August 12, 2025 updated by: Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
The Effect of Body Mass Index on Patient Outcomes During Low-flow Anaesthesia for Major Gynaecological Cancer Surgery: a Prospective Observational Study
This study was designed as a prospective observational study.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this study, it was planned to evaluate the effect of body mass index on patient outcomes during low flow anaesthesia in patients undergoing gynaecological cancer surgery on the specified dates.
ASA II and III patients over 18 years of age were included in the study.
Low flow anaesthesia is routinely applied in open gynaecological cancer surgeries in our clinic.
The relationship between body mass index and intraoperative haemodynamic and mechanical ventilator values and postoperative patient outcomes will be evaluated.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Duygu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
A total of 40 patients were planned for this study
Description
Inclusion Criteria:
- Patients with ASA II-III
- >18 years
- Patients undergoing major open surgery for endometrium, cervix or ovarian ca in gynaecological oncology clinic
Exclusion Criteria:
- Patients who refused to participate in the study
- Cerebrovascular disease
- Those with severe pulmonary disease
- Those with serious cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
obese patients undergoing low-flow anaesthesia
Low-flow anaesthesia was performed in patients with a body mass index between 30-40
|
The investigator planned to evaluate the effect of body mass index on patient outcomes during low-flow anesthesia in patients undergoing gynecologic cancer surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative hospital stay
Time Frame: up to 10 days postoperative
|
The primary aim of this study was to evaluate the duration of postoperative hospital stay
|
up to 10 days postoperative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative cerebral oxygenation
Time Frame: intraoperative process
|
Our other aim was to evaluate right and left hemisphere cerebral oxygenation at certain time periods.
|
intraoperative process
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mychaskiw G 2nd. Low and minimal flow anesthesia: Angels dancing on the point of a needle. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):423-5. doi: 10.4103/0970-9185.101883. No abstract available.
- Oterkus M, Donmez I, Nadir AH, Rencuzogullari I, Karabag Y, Binnetoglu K. The effect of low flow anesthesia on hemodynamic and peripheral oxygenation parameters in obesity surgery. Saudi Med J. 2021 Mar;42(3):264-269. doi: 10.15537/smj.2021.42.3.20200575.
- Akbas S, Ozkan AS. Comparison of effects of low-flow and normal-flow anesthesia on cerebral oxygenation and bispectral index in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: a prospective, randomized clinical trial. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):19-26. doi: 10.5114/wiitm.2018.77265. Epub 2018 Jul 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
March 1, 2025
Study Registration Dates
First Submitted
September 27, 2024
First Submitted That Met QC Criteria
October 9, 2024
First Posted (Actual)
October 10, 2024
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
August 12, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.