OncologyNCT06430593
Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries
An observational study of Oncology, run by Başakşehir Çam & Sakura City Hospital.
Trial summary
Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- low-flow anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Jan 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ages 18-75, ASA I,II, Patients undergoing robotic-assisted laparoscopic surgery
Who may be able to join
- Ages 18-75
- ASA I,II
- Patients undergoing robotic-assisted laparoscopic surgery
Who cannot join
- ASA III,IV,V
- Those with serious cardiac, respiratory, hepatic, renal disease
- People with mental status disorders, psychiatric illnesses
- Patients with hearing problems and glaucoma
- Desire to be out of work
About this study
Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In our clinic, we routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
Read the detailed description
Robotic surgery is the performance of laparoscopic surgery using a robotic interface. The robotic surgery system used today is called Da Vinci S. In surgeries performed with the help of a robot, the surgeon can work more precisely and with greater maneuverability. Therefore, an operation can be performed that is less traumatic for the patient than other methods.Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In these applications, fresh gas flow in anesthesia systems can be made with traditional high, normal or low flow strategies, depending on the preference of the clinicians.Low-flow anesthesia creates a breathing air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow amounts does not pose a safety risk for patients, and that the use of low-flow anesthesia methods should be more widespread due to the advantages it provides. In our clinic, investigators routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
- Conditions
- Oncology
- Being tested
- low-flow anesthesia
- Keywords
- low-flow anesthesia, robotic-assisted surgery, general anesthesia
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-flow anesthesiaProcedure or surgery
Also called normal flow anesthesia
0,5 l/min >1 l/min
| Study group | Role | What they receive |
|---|---|---|
| low-flow anesthesia | 0,5 lt/min Receives: Procedure: low-flow anesthesia | |
| normal flow anesthesia | >1 lt/min Receives: Procedure: low-flow anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Parameters
It was aimed to compare heart rates in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Measured: Perioperative period(approximately 3-6 hours)
Hemodynamic Parameters
It was aimed to compare blood pressure in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Measured: Perioperative period(approximately 3-6 hours)
Respiratory parameters
It was aimed to compare oxygen saturation in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Measured: Perioperative period(approximately 3-6 hours)
Respiratory parameters
It was aimed to compare endtidal carbon dioxide in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Measured: Perioperative period(approximately 3-6 hours)
Inhalation agent (sevoflurane) consumption
It was aimed to compare inhalation agent (sevoflurane) consumption (lt) in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Measured: Perioperative period(approximately 3-6 hours)
Soda lime consumption
It was aimed to compare soda lime consumption in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Soda lime consumption refers to the number of changes of the soda lime canister.
Measured: Perioperative period(approximately 3-6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal AKCA, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430593
- Sponsor's protocol ID
- 2024- 183
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT06430593
- Acronym / sponsor ID
- 2024- 183
- Conditions
- Oncology
- Keywords
- low-flow anesthesia, robotic-assisted surgery, general anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 28 May 2024 (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.
Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In our clinic, we routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
Detailed description
Robotic surgery is the performance of laparoscopic surgery using a robotic interface. The robotic surgery system used today is called Da Vinci S. In surgeries performed with the help of a robot, the surgeon can work more precisely and with greater maneuverability. Therefore, an operation can be performed that is less traumatic for the patient than other methods.Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In these applications, fresh gas flow in anesthesia systems can be made with traditional high, normal or low flow strategies, depending on the preference of the clinicians.Low-flow anesthesia creates a breathing air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow amounts does not pose a safety risk for patients, and that the use of low-flow anesthesia methods should be more widespread due to the advantages it provides. In our clinic, investigators routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.
To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-flow anesthesia | – | Procedure: low-flow anesthesia0,5 lt/min |
| normal flow anesthesia | – | Procedure: low-flow anesthesia>1 lt/min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ages 18-75, ASA I,II, Patients undergoing robotic-assisted laparoscopic surgery
Key inclusion criteria (3 listed)
- Ages 18-75
- ASA I,II
- Patients undergoing robotic-assisted laparoscopic surgery
Key exclusion criteria (5 listed)
- ASA III,IV,V
- Those with serious cardiac, respiratory, hepatic, renal disease
- People with mental status disorders, psychiatric illnesses
- Patients with hearing problems and glaucoma
- Desire to be out of work
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 |
|---|---|---|
| low-flow anesthesiaAlso: normal flow anesthesia0,5 l/min >1 l/min | Procedure or surgery | low-flow anesthesia, normal flow anesthesia |
Primary outcome
Hemodynamic Parameters
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare heart rates in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Hemodynamic Parameters
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare blood pressure in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Respiratory parameters
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare oxygen saturation in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Respiratory parameters
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare endtidal carbon dioxide in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Inhalation agent (sevoflurane) consumption
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare inhalation agent (sevoflurane) consumption (lt) in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia.
Soda lime consumption
Time frame: Perioperative period(approximately 3-6 hours)
It was aimed to compare soda lime consumption in patients undergoing low flow (0.5 lt/min) and normal flow (>1 lt/min) anesthesia. Soda lime consumption refers to the number of changes of the soda lime canister.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Başakşehir Çam & Sakura City Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hemodynamic Parameters (time frame: Perioperative period(approximately 3-6 hours)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.