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

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ClinicalTrials.gov Identifier: NCT03563833
Recruitment Status : Unknown
Verified June 2018 by Şule Batçık, Recep Tayyip Erdogan University Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Şule Batçık, Recep Tayyip Erdogan University Training and Research Hospital

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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
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Primary Outcome Measures :
  1. Thiol Disulfide Balance [ Time Frame: 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 :
  1. StO2 [ Time Frame: For two groups; simultaneously, 30 min before the start of surgery, 60th min of the surgery ]
    Change of Peripheral Tissue Oxygen Saturation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563833


Contacts
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Contact: Şule Batçık, Asst. Prof. +904642130491 ext 2128 drsulebatcik@gmail.com
Contact: Leyla Kazancıoğlu, Asst. Prof. +904642130491 ext 2128 leylahotaman@hotmail.com

Locations
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Turkey
Recep Tayyip Erdoğan University Training and Research Hospital Recruiting
Rize, Turkey, 53200
Contact: Şule Batçık, Asst. Prof.         
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Şule Batçık, Asst. Prof. Recep Tayyip Erdoğan University Medical School Department of Anesthesia
More Information
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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: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Şule Batçık, Recep Tayyip Erdogan University Training and Research Hospital:
Minimal Flow Anesthesia
Thiol/disulfide balance
Tissue oxygen saturation
hypotensive anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs