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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03563833

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress	Other: Minimal Flow Anesthesia Other: High Flow Anesthesia	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

May 4, 2018

Anticipated Primary Completion Date :

Oct 31, 2018

Anticipated Study Completion Date :

Nov 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Thiol Disulfide Balance [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]
Change of Oxidative Stress Marker

Secondary Outcome Measures

StO2 [For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery]
Change of Peripheral Tissue Oxygen Saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Recep Tayyip Erdoğan University Training and Research Hospital	Rize		Turkey	53200

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Şule Batçık, Assistant Professor, Recep Tayyip Erdogan University Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03563833

Other Study ID Numbers:

2018/64

First Posted:

Jun 20, 2018

Last Update Posted:

Jun 20, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Şule Batçık, Assistant Professor, Recep Tayyip Erdogan University Training and Research Hospital

Minimal Flow Anesthesia

Thiol/disulfide balance

Tissue oxygen saturation

hypotensive anesthesia

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jun 20, 2018