The Effect of Minimal Flow Sevoflurane Anesthesia

Study Overview
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Brief Summary
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Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Detailed Description
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Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation. Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations. Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

Official Title
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The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial.

Conditions
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Anesthesia Awareness, Anesthesia; Functional

Intervention / Treatment
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* Drug: Sevoflurane inhalant product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiologists) class I-II The operation time between 60-180 minutes Exclusion Criteria: Severe cardiac disease COPD (Chronic Obstructive Pulmonary Disease) Severe liver and kidney disease, Diabetes mellitus Morbid obesity Alcohol and/or drug addiction Risk or history of malignant hyperthermia Pregnancy and lactation Emergency cases Operation time less than 60 minutes and longer than 180 minutes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: they will divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M<br>Group M is minimal flow anesthesia group with fresh gas flow 0,5 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 0,5 L.min-1 flow under general anesthesia. | Drug: Sevoflurane inhalant product<br>* The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.<br>* Other names: Sevorane;|
| Active Comparator: Group H<br>Group H is high flow anesthesia group with fresh gas flow 4 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 4 L.min-1 flow under general anesthesia. | Drug: Sevoflurane inhalant product<br>* The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.<br>* Other names: Sevorane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE IN P/F | PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). P/F ratio is a widely used clinical indicator of hypoxaemia | from the beginning to the end of anesthesia | 
| CHANGE IN PaCO2 | The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood. | from the beginning to the end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volatile agent consumption amount | the total amount of volatile agent (sevoflurane) consumed at the end of the surgery | from the beginning to the end of anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimal flow anesthesia, laparoscopic cholecystectomy