Morbid ObesityOxygenationNCT03721536
Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients
A study testing hemodynamic parameters and arterial blood gase in people with Morbid Obesity and Hemodynamic Instability, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Hemodynamic Instability, Bariatric Surgery Candidate
- What is being tested?
- hemodynamic parameters and arterial blood gase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2018to 1 Nov 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
- Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
- Aged 18-65 years old,
- BMI>40
Who cannot join
- Pregnant
- Uncontrolled diabetes mellitus,
- Cardiovascular disease,
- Pulmonary disease,
- Cerebrovascular disease,
- Drug and alcohol addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial
Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.
Read the detailed description
Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.
Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.
- Being tested
- hemodynamic parameters, arterial blood gase
- Keywords
- Morbidly obese patients, Bariatric surgery, Arterial blood analysis
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic parametersDiagnostic test
Also called heart rate, mean arterial pressure, peripheral oxygen saturation, End-tidal Carbon Dioxide
vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide
arterial blood gaseDiagnostic test
Also called partial oxygen pressure, partial carbon dioxide pressure
Arterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control.
| Study group | Role | What they receive |
|---|---|---|
| low-flow anesthesia | Active comparator | Patients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation. Receives: Diagnostic Test: hemodynamic parameters; Diagnostic Test: arterial blood gase |
| normal-flow anesthesia | Active comparator | Patients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation. Receives: Diagnostic Test: hemodynamic parameters; Diagnostic Test: arterial blood gase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of partial oxygen pressure
The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary outcomes (3)
Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start18 Oct 2018
- Primary completion30 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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, Asst Prof, Study director, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721536
- Sponsor's protocol ID
- sedatakbas4
- Acronym
- Oxygenation
- Status last verified
- Jan 2019
- First submitted
- 18 Oct 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03721536
- Acronym / sponsor ID
- Oxygenation / sedatakbas4
- Keywords
- Morbidly obese patients, Bariatric surgery, Arterial blood analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 26 Oct 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.
Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.
Detailed description
Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.
Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-flow anesthesia | Active comparator | Diagnostic Test: hemodynamic parameters, Diagnostic Test: arterial blood gasePatients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation. |
| normal-flow anesthesia | Active comparator | Diagnostic Test: hemodynamic parameters, Diagnostic Test: arterial blood gasePatients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
- Aged 18-65 years old,
- BMI>40
Key exclusion criteria (6 listed)
- Pregnant
- Uncontrolled diabetes mellitus,
- Cardiovascular disease,
- Pulmonary disease,
- Cerebrovascular 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 |
|---|---|---|
| hemodynamic parametersAlso: heart rate, mean arterial pressure, peripheral oxygen saturation, End-tidal Carbon Dioxidevital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide | Diagnostic test | low-flow anesthesia, normal-flow anesthesia |
| arterial blood gaseAlso: partial oxygen pressure, partial carbon dioxide pressureArterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control. | Diagnostic test | low-flow anesthesia, normal-flow anesthesia |
Primary outcome
The level of partial oxygen pressure
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis
3 secondary outcomes
Heart rate
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
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 7 Jan 2019.
- BackgroundNunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4
- Low-flow anaesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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, Asst Prof 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 hemodynamic parameters and arterial blood gase in people with Morbid Obesity and Hemodynamic Instability, 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 6 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 7 Jan 2019. 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. 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?
The level of partial oxygen pressure (time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)). 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 NCT03721536, which also lists 1 linked publication.
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 7 Jan 2019.