## Protocol Section
### Identification Module
**NCT ID:** NCT06430593

**Brief Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries

**Official Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries

#### Organization Study ID Info
**ID:** 2024- 183
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Hilal AKCA

**Investigator Title:** Anesthesiologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Oncology

**Keywords:**

- low-flow anesthesia

- robotic-assisted surgery

- general anesthesia

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 68

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 0,5 lt/min

**Intervention Names:**

- Procedure: low-flow anesthesia

**Label:** low-flow anesthesia

#### Arm Group 2

**Description:** \>1 lt/min

**Intervention Names:**

- Procedure: low-flow anesthesia

**Label:** normal flow anesthesia

### Interventions

#### Intervention 1

**Arm Group Labels:**

- low-flow anesthesia

- normal flow anesthesia

**Description:** 0,5 l/min \>1 l/min

**Name:** low-flow anesthesia

**Other Names:**

- normal flow anesthesia

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** It was aimed to compare heart rates in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.

**Measure:** Hemodynamic Parameters

**Time Frame:** Perioperative period(approximately 3-6 hours)

**Description:** It was aimed to compare blood pressure in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.

**Measure:** Hemodynamic Parameters

**Time Frame:** Perioperative period(approximately 3-6 hours)

**Description:** It was aimed to compare oxygen saturation in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.

**Measure:** Respiratory parameters

**Time Frame:** Perioperative period(approximately 3-6 hours)

**Description:** It was aimed to compare endtidal carbon dioxide in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia.

**Measure:** Respiratory parameters

**Time Frame:** Perioperative period(approximately 3-6 hours)

**Description:** 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.

**Measure:** Inhalation agent (sevoflurane) consumption

**Time Frame:** Perioperative period(approximately 3-6 hours)

**Description:** 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.

**Measure:** Soda lime consumption

**Time Frame:** Perioperative period(approximately 3-6 hours)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Ages 18-75
* ASA I,II
* Patients undergoing robotic-assisted laparoscopic surgery

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Ages 18-75, ASA I,II, Patients undergoing robotic-assisted laparoscopic surgery

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
