Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications

Investigation of the Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and Peripheral Tissue Saturation (StO2) in Hypotensive Anesthesia Applications

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress
• Intervention / Treatment: Other: Minimal Flow Anesthesia; Other: High Flow Anesthesia

Detailed Description

The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

Minimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.

Hypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.

The use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.

Determining the ideal anesthesia technique in terms of oxidative stress and tissue perfusion will reduce intra- and postoperative risks by protecting patients from the harmful effects of anesthesia.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53200
    • Recruiting
    • Recep Tayyip Erdogan University Training and Research Hospital
    • Contact: Şule Batçık, Asst. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
• ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,

Exclusion Criteria:

• operations in less than one hour
• uncontrolled hypertension
• DM (Diabetes Mellitus)
• cerebrovascular disease
• coagulopathy
• morbid obesity ((BMI ≥ 35)
• renal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimal Flow Anesthesia; Minimal Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5). In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.	Other: Minimal Flow Anesthesia; Minimal Flow Anesthesia with 0,4 L min-1
Other: High Flow Anesthesia; High Flow Anesthesia (50% O2, 50% air), Desflurane (MAC = 4,5) In hypotensive anesthesia application; Remifentanil will be used at infusion rates of 0.025-0.1μg / kg / min after a loading dose of 1 μg / kg / min, with mean Arterial Pressure 55-65 mmHg. Before the induction of anesthesia and 30 minutes of anesthesia, 2 ml of venous blood sample will be taken from the patients and simultaneous tissue oxygen saturation will be recorded. Serum thiol disulfide levels obtained from the blood sample of the recipient will be studied in the biochemistry research laboratory using the method developed by Erel et al.	Other: High Flow Anesthesia; High Flow Anesthesia with 2 L min-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thiol Disulfide Balance	Change of Oxidative Stress Marker	For two groups; First blood sample will be taken 30 min before the start of surgery, second blood sample will be taken at the 60th min of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
StO2	Change of Peripheral Tissue Oxygen Saturation	For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Investigators: Principal Investigator: Şule Batçık, Asst. Prof., Recep Tayyip Erdoğan University Medical School Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2018
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Tissue oxygen saturation; hypotensive anesthesia; Minimal Flow Anesthesia; Thiol/disulfide balance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2018/64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No