Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611449
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-30
Brief Title:
The Effect of Minimal Flow Anesthesia on Oxidative and Neuroendocrine Stress Response
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Minimal Flow Anesthesia on Oxidative and Neuroendocrine Stress Response
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients under general anesthesia who are unconscious and have stopped spontaneous breathing are actively ventilated with anesthesia machines ensuring the anesthesia gas reaches the lungs and then the bloodstream Not all the gas reaching the lungs during respiration is used a small portion is absorbed by the body and most of it is expelled during exhalation After eliminating the carbon dioxide in the expired gas it is more suitable to re-breathe the remaining gas The portion taken by the patient needs to be provided for the next breath and this added gas is called fresh gas flow Today low flow anesthesia is defined when the fresh gas flow rate is 05-1 Lmin minimal flow anesthesia when it is 025-05 Lmin and metabolic flow anesthesia when it is 025 Lmin Our study will evaluate the effects of minimal flow anesthesia which is widely used today due to its advantages on oxidative stress and neuroendocrine stress response
Detailed Description:
General anesthesia is characterized by anesthesia analgesia amnesia and muscle relaxation The most common practice today for maintaining anesthesia after induction is to add a low-density effective inhalation anesthetic to an oxygenair mixture Patients who are unconscious and have stopped spontaneous breathing are actively ventilated with anesthesia machines ensuring the anesthesia gas reaches the lungs and then the bloodstream Minute ventilation refers to the total amount of gas oxygen air and anesthetic agent mixture a patient breathes in one minute which is approximately 5-6 L in a normal adult weighing 70 kg
During respiration not all the gas reaching the lungs is used a small portion is absorbed by the body and most of it is expelled during exhalation After eliminating the carbon dioxide in the expired gas it is more suitable to re-breathe the remaining gas for lung physiology environmental protection and cost-effectiveness The portion taken by the patient needs to be provided for the next breath and this added gas is called fresh gas flow
Today in adults low flow anesthesia is defined when the fresh gas flow rate is 05-1 Lmin minimal flow anesthesia when it is 025-05 Lmin and metabolic flow anesthesia when it is 025 Lmin Reducing the fresh gas flow has positive effects on the patients health under anesthesia environmental protection and cost-effectiveness as well as reducing pathologies in the operating room staff due to air pollution Low flow anesthesia has been shown to have no adverse effects on oxygenation ventilation organ functions or hemodynamic parameters It does not affect any surgical procedure
The acute stress response associated with surgery and anesthesia is connected to the neuroendocrine-metabolic system and the inflammatory-immune system In response to surgical stress adrenocorticotropic hormoneACTH is released from the pituitary gland via corticotropin-releasing hormoneCRH ACTH stimulates the adrenal cortex to release glucocorticoid cortisol Both innate and adaptive immune cells play a role in the stress response to surgery Cytokines mediate the local inflammatory response seen with tissue damage Pro-inflammatory cytokines such as interleukin-6 IL-6 are released peaking in the first 24 hours post-surgery
Previous studies have shown an increase in cortisol ACTH and IL-6 values on the first postoperative day their changes were recorded by measuring them at induction the end of surgery and at postoperative 12 and 24 hours The body contains unstable molecules defined as free oxygen radicals These molecules are balanced by antioxidant molecules The imbalance in favor of oxidants leads to oxidative stress causing a series of tissue damage The biochemical markers indicating this balance are total antioxidant status TAS and total oxidative status TOS
Our study will evaluate the effects of minimal flow anesthesia which is widely used today due to its advantages on oxidative stress and neuroendocrine stress response
Research Methodology Our research is a prospective randomized controlled clinical study Patients aged 18-65 undergoing elective septorhinoplasty classified as American Society of AnesthesiologistsASA 1-2 will be included Informed consent will be obtained from patients who volunteer for the study
Patients included in the study will be divided into two groups using a closed envelope method After reaching a minimum alveolar concentration MAC value of 09-10 group 1 minimal flow group n16 will receive maintenance anesthesia with minimal fresh gas flow and group 2 high flow group n16 will receive maintenance anesthesia with high fresh gas flow Group 1 will receive maintenance anesthesia with 80-100 O2 and 35-45 sevoflurane at a fresh gas flow rate of 03-04 Lmin Group 2 will receive maintenance anesthesia with 40-45 oxygen-air mixture 2-25 sevoflurane and a fresh gas flow rate of 4 Lmin
Levels of Total Antioxidant Status TAS Total Oxidative Status TOS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured from blood samples taken from the patients Before the surgery a 20-gauge venous cannula will be placed in the antecubital region for blood sampling to avoid repeated invasive procedures Immediately before the surgery 8 ml of blood will be taken as the first sample The sample will be placed in 3 ml ethylenediaminetetraacetic acid EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C At the end of surgery 5 ml of blood will be taken as the second sample before extubation placed in a gel tube and sent to the biochemistry laboratory to be stored at -80C At the 6th postoperative hour 8 ml of blood will be taken as the third sample placed in 3 ml EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C At the 18th postoperative hour 8 ml of blood will be taken as the fourth sample placed in 3 ml EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C A total of 30 ml of blood samples will be collected from the patient The blood samples will be centrifuged at 3000 rpm for 10 minutes and the separated sera will be stored at -80C for analysis
Patients will be discharged with appropriate treatment deemed suitable by the surgical team The levels of Total Oxidative Status TOS Total Antioxidant Status TAS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured in the blood sample taken before induction TASTOS will be measured in the second blood sample taken at the end of the surgery Total Oxidative Status TOS Total Antioxidant Status TAS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured in blood samples taken at the 6th and 18th postoperative hours Hemodynamic parameters visual analogue pain score VAS and nausea-vomiting status will be recorded at the 6th and 18th postoperative hours After centrifuging the blood samples they will be stored at -80C and the specified biomarkers will be evaluated in the laboratory after all samples are collected The results will be used in our research after statistical analysis
Data will be analyzed using the Statistical Package for the Social SciencesSPSS-statistics 220 software package Categorical variables will be expressed as numbers and percentages while continuous variables will be presented as median mean and standard deviation The chi-square test will be used to compare differences between categorical variables The normal distribution of continuous variables will be assessed by the Shapiro-Wilk test The Students t-test will be used for parametric data and the Mann-Whitney U test for non-parametric data to compare continuous variables between the two groups A p-value of 005 will be considered significant in all tests
During respiration not all the gas reaching the lungs is used a small portion is absorbed by the body and most of it is expelled during exhalation After eliminating the carbon dioxide in the expired gas it is more suitable to re-breathe the remaining gas for lung physiology environmental protection and cost-effectiveness The portion taken by the patient needs to be provided for the next breath and this added gas is called fresh gas flow
Today in adults low flow anesthesia is defined when the fresh gas flow rate is 05-1 Lmin minimal flow anesthesia when it is 025-05 Lmin and metabolic flow anesthesia when it is 025 Lmin Reducing the fresh gas flow has positive effects on the patients health under anesthesia environmental protection and cost-effectiveness as well as reducing pathologies in the operating room staff due to air pollution Low flow anesthesia has been shown to have no adverse effects on oxygenation ventilation organ functions or hemodynamic parameters It does not affect any surgical procedure
The acute stress response associated with surgery and anesthesia is connected to the neuroendocrine-metabolic system and the inflammatory-immune system In response to surgical stress adrenocorticotropic hormoneACTH is released from the pituitary gland via corticotropin-releasing hormoneCRH ACTH stimulates the adrenal cortex to release glucocorticoid cortisol Both innate and adaptive immune cells play a role in the stress response to surgery Cytokines mediate the local inflammatory response seen with tissue damage Pro-inflammatory cytokines such as interleukin-6 IL-6 are released peaking in the first 24 hours post-surgery
Previous studies have shown an increase in cortisol ACTH and IL-6 values on the first postoperative day their changes were recorded by measuring them at induction the end of surgery and at postoperative 12 and 24 hours The body contains unstable molecules defined as free oxygen radicals These molecules are balanced by antioxidant molecules The imbalance in favor of oxidants leads to oxidative stress causing a series of tissue damage The biochemical markers indicating this balance are total antioxidant status TAS and total oxidative status TOS
Our study will evaluate the effects of minimal flow anesthesia which is widely used today due to its advantages on oxidative stress and neuroendocrine stress response
Research Methodology Our research is a prospective randomized controlled clinical study Patients aged 18-65 undergoing elective septorhinoplasty classified as American Society of AnesthesiologistsASA 1-2 will be included Informed consent will be obtained from patients who volunteer for the study
Patients included in the study will be divided into two groups using a closed envelope method After reaching a minimum alveolar concentration MAC value of 09-10 group 1 minimal flow group n16 will receive maintenance anesthesia with minimal fresh gas flow and group 2 high flow group n16 will receive maintenance anesthesia with high fresh gas flow Group 1 will receive maintenance anesthesia with 80-100 O2 and 35-45 sevoflurane at a fresh gas flow rate of 03-04 Lmin Group 2 will receive maintenance anesthesia with 40-45 oxygen-air mixture 2-25 sevoflurane and a fresh gas flow rate of 4 Lmin
Levels of Total Antioxidant Status TAS Total Oxidative Status TOS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured from blood samples taken from the patients Before the surgery a 20-gauge venous cannula will be placed in the antecubital region for blood sampling to avoid repeated invasive procedures Immediately before the surgery 8 ml of blood will be taken as the first sample The sample will be placed in 3 ml ethylenediaminetetraacetic acid EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C At the end of surgery 5 ml of blood will be taken as the second sample before extubation placed in a gel tube and sent to the biochemistry laboratory to be stored at -80C At the 6th postoperative hour 8 ml of blood will be taken as the third sample placed in 3 ml EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C At the 18th postoperative hour 8 ml of blood will be taken as the fourth sample placed in 3 ml EDTA and 5 ml gel tubes and sent to the biochemistry laboratory to be stored at -80C A total of 30 ml of blood samples will be collected from the patient The blood samples will be centrifuged at 3000 rpm for 10 minutes and the separated sera will be stored at -80C for analysis
Patients will be discharged with appropriate treatment deemed suitable by the surgical team The levels of Total Oxidative Status TOS Total Antioxidant Status TAS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured in the blood sample taken before induction TASTOS will be measured in the second blood sample taken at the end of the surgery Total Oxidative Status TOS Total Antioxidant Status TAS ACTH adrenocorticotropic hormone cortisol and IL-6 inflammatory cytokine will be measured in blood samples taken at the 6th and 18th postoperative hours Hemodynamic parameters visual analogue pain score VAS and nausea-vomiting status will be recorded at the 6th and 18th postoperative hours After centrifuging the blood samples they will be stored at -80C and the specified biomarkers will be evaluated in the laboratory after all samples are collected The results will be used in our research after statistical analysis
Data will be analyzed using the Statistical Package for the Social SciencesSPSS-statistics 220 software package Categorical variables will be expressed as numbers and percentages while continuous variables will be presented as median mean and standard deviation The chi-square test will be used to compare differences between categorical variables The normal distribution of continuous variables will be assessed by the Shapiro-Wilk test The Students t-test will be used for parametric data and the Mann-Whitney U test for non-parametric data to compare continuous variables between the two groups A p-value of 005 will be considered significant in all tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None