The Effect of Minimal Flow Anesthesia on Oxidative and Neuroendocrine Stress Response

NCT06611449 | Active Not Recruiting DMC

• 1 other identifier: hdeniz.001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 0.5-1 L/min, minimal flow anesthesia when it is 0.25-0.5 L/min, and metabolic flow anesthesia when it is 0.25 L/min. 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

Conditions

Low Flow Anesthesia; Oxidative Stress; Neuroinflammatory Response

Keywords

Low Flow Anesthesia; Oxidative Stress; Neuroinflammatory Response

Outcome Measures

Primary Outcomes (5)

• Interleukin 6 (IL-6) level

  Proinflammatory cytokines (Biochemical marker)

  Just before surgery begins, postoperative 6th hour and postoperative 18th hour

• Adrenocorticotropic hormone (ACTH) level

  Adrenocorticotropic hormone(Biochemical marker)

  Just before surgery begins, postoperative 6th hour and postoperative 18th hour

• Cortisol level

  Biochemical marker

  Just before surgery begins, postoperative 6th hour and postoperative 18th hour

• Total oxidative status (TOS) Level

  Total oxidative status; blood biochemical tests are used to calculate oxidative indicators.

  Just before surgery begins, end of surgery, postoperative 6th hour and postoperative 18th hour

• Total antioxidative status( TAS) Level

  Total antioxidative status; blood biochemical tests are used to calculate oxidative indicators.

  Just before surgery begins, end of surgery, postoperative 6th hour and postoperative 18th hour

Secondary Outcomes (6)

• amount of bleeding

  end of surgery

• Amount of volatile anesthetic use

  End of anesthesia

• Body temperature change

  From the beginning of anesthesia to the 18th postoperative hour

• The presence of nausea and vomiting

  From the recovery of anesthesia to the 18th postoperative hour

• Assessment of pain

  From the recovery of anesthesia to the 18th postoperative hour

Study Arms (2)

The minimal flow group

ACTIVE COMPARATOR

As soon as mechanical ventilation begins, sevoflurane at a concentration of 3% and a fresh gas flow of 4 L/min with 40-45% oxygen will be used to maintain ventilation until the MAC value reaches 0.9-1.0 For patients in Group 1:the minimal flow group (n=16), maintenance anesthesia will be provided with 80-100% O2 and 3.5-4.5% sevoflurane at a fresh gas flow rate of 0.3-0.5 L/min(minimal fresh gas flow anesthesia) Near the end of the operation, the maintenance anesthetics will be discontinued, and the fresh gas flow will be increased to 6 L/min

Other: The minimal flow anesthesia with sevoflurane group

The high flow group

ACTIVE COMPARATOR

As soon as mechanical ventilation begins, sevoflurane at a concentration of 3% and a fresh gas flow of 4 L/min with 40-45% oxygen will be used to maintain ventilation until the MAC value reaches 0.9-1.0 For patients in Group 2: the high flow group (n=16), maintenance anesthesia will be provided with a 40-45% oxygen-air mixture, 2-2,5% sevoflurane, and a fresh gas flow rate of 4 L/min (high fresh gas flow anesthesia) Near the end of the operation, the maintenance anesthetics will be discontinued, and the fresh gas flow will be increased to 6 L/min

Other: The high flow anesthesia with sevoflurane group

Interventions

The minimal flow anesthesia with sevoflurane group OTHER

In the minimal flow group, anesthesia will be maintained with minimal fresh gas flow (0.3-0.5 L/min). The effect of minimal flow anesthesia on oxidative and neuroendocrine stress response will be evaluated by the levels of: IL-6 (proinflammatory cytokine), ACTH (adrenocorticotropic hormone), Cortisol, TAS/TOS (total antioxidant/oxidant status) measured from blood samples. Blood samples will be taken from the antecubital area before the surgery begins, thus eliminating the need for repeated invasive procedures. Blood samples will be taken from the patients just before the surgery begins, at the end of the surgery, and at the 6th and 18th hours after the surgery.

The minimal flow group

The high flow anesthesia with sevoflurane group OTHER

Maintenance of anesthesia in the high flow group will be provided with a high fresh gas flow (4 L/min). The effect of high flow anesthesia on oxidative and neuroendocrine stress response will be evaluated by the levels of: IL-6 (proinflammatory cytokine), ACTH (adrenocorticotropic hormone), Cortisol, TAS/TOS (total antioxidant/oxidant status) measured from blood samples. Blood samples will be taken from the antecubital area before the surgery begins, thus eliminating the need for repeated invasive procedures. Blood samples will be taken from the patients just before the surgery begins, at the end of the surgery, and at the 6th and 18th hours after the surgery.

The high flow group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Scheduled for elective septorhinoplasty
• ASA (physical status) 1-2

You may not qualify if:

• ASA (physical status) III-IV
• Under 18 or over 65
• Pregnant individuals
• Serious cardiovascular disease or arrhythmia
• Chronic obstructive pulmonary disease
• Severe respiratory failure
• Uncontrolled cerebrovascular disease
• Hepatic or renal dysfunction
• Allergy to propofol, fentanyl, rocuronium, sevoflurane
• Pituitary gland disease (e.g., pituitary adenoma)
• Adrenal gland disease (e.g., pheochromocytoma, Cushing's disease)
• Immune deficiency
• Neuroendocrine system disease
• BMI \> 40
• Patients who refuse to provide written informed consent.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• Cusack B, Buggy DJ. Anaesthesia, analgesia, and the surgical stress response. BJA Educ. 2020 Sep;20(9):321-328. doi: 10.1016/j.bjae.2020.04.006. Epub 2020 Jul 21. No abstract available.

  PMID: 33456967 BACKGROUND

• Kasikara H, Dumanli Ozcan AT, Bicer CK, Senat A, Yalcin A, Altin C, Mustafa Aksoy S, But A. The effect of low flow anesthesia with sevoflurane on oxidative status: A prospective, randomized study. Saudi Med J. 2022 Mar;43(3):227-235. doi: 10.15537/smj.2022.43.3.20210876.

  PMID: 35256489 BACKGROUND

Study Officials

• Resident Doctor

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: September 25, 2024
• Study Start: June 30, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)