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

NCT ID: NCT03563833

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-04

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Minimal Flow Anesthesia

Intervention Type OTHER

Minimal Flow Anesthesia with 0,4 L min-1

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.

Group Type OTHER

High Flow Anesthesia

Intervention Type OTHER

High Flow Anesthesia with 2 L min-1

Interventions

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Minimal Flow Anesthesia

Minimal Flow Anesthesia with 0,4 L min-1

Intervention Type OTHER

High Flow Anesthesia

High Flow Anesthesia with 2 L min-1

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Şule Batçık

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şule Batçık, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Recep Tayyip Erdoğan University Medical School Department of Anesthesia

Locations

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Recep Tayyip Erdoğan University Training and Research Hospital

Rize, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Şule Batçık, Asst. Prof.

Role: CONTACT

+904642130491 ext. 2128

Leyla Kazancıoğlu, Asst. Prof.

Role: CONTACT

+904642130491 ext. 2128

Facility Contacts

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Şule Batçık, Asst. Prof.

Role: primary

Other Identifiers

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2018/64

Identifier Type: -

Identifier Source: org_study_id

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