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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563833
• Other study ID #: 2018/64
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2018
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Sule Batçik, Asst. Prof.
• Phone: +904642130491
• Email: drsulebatcik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Other:
• Minimal Flow Anesthesia
Minimal Flow Anesthesia with 0,4 L min-1
• High Flow Anesthesia
High Flow Anesthesia with 2 L min-1

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Training and Research Hospital	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	StO2	Change of Peripheral Tissue Oxygen Saturation	For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery