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Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03501563
Collaborator
(none)
80
Enrollment
1
Location
8.8
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oxidative stress at the cellular level and the effects of the antioxidant system on the anesthetic drugs make the anesthesia method more important. Hypotensive anesthesia or controlled hypotension is an anesthetic technique routinely used in many operations (ENT, orthopedic, plastic surgery, etc.) to reduce intraoperative bleeding and to provide a more open surgical area.

In this study, investigators aimed to investigate the effects of hypotensive anesthesia on thiol / disulfide balance from oxidative stress markers.

Hypotensive anesthesia is caused by hypoperfusion and hypoxia-induced oxidative stresses at the tissue level and can initiate cell damage. Many methods can be used alone or in combination to create hypotensive anesthesia. İnvestigators will investigate whether hypotensive anesthesia causes an effect on the cellular level.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will be performed prospectively with 80 participants with ASA 1-2, aged 18-60 years, undergoing hypotensive anesthesia in the operation of the septoplasty in Recep Tayyip Erdoğan University Medical Faculty Training and Research Hospital. Participants with uncontrolled hypertension, diabetes mellitus, cerebrovascular disease, cogulopathy, morbid obesity (BMI ≥35) and renal disease will not be taken. Anesthesia induction and management will be standardized. Hypotension in the participants will be maintained by reducing the mean arterial pressure (MAP) by 30% or 55-65 mmHg according to the initial value. In the study, the heart rate (HR), MAP, peripheral O2 saturation (SpO2), ETCO2 (end-tidal carbon dioxide) values, and BIS (Bispectral index) values showing anesthesia depth are to be followed. Participants will receive venous blood sample of up to 2 ml before the anesthesia induction and 10 minutes to finish of the hypotensive anesthesia, from the untreated vein. Thiol disulfide levels from this blood sample will be studied in the biochemistry research laboratory using the method developed by Erel et al.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Effects of Hypotensive Anesthesia on Thiol Disulphide Balance
    Actual Study Start Date :
    Apr 5, 2018
    Anticipated Primary Completion Date :
    Sep 30, 2018
    Anticipated Study Completion Date :
    Dec 30, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Case Group

    Participants with ASA 1-2, aged 18-60 years, undergoing hypotensive anesthesia in the operation of the septoplasty in Recep Tayyip Erdoğan University Medical Faculty Training and Research Hospital. Participants with uncontrolled hypertension, diabetes mellitus, cerebrovascular disease, cogulopathy, morbid obesity (BMI ≥35) and renal disease will not be taken. Participants were first pre-medicated with an infusion of midazolam 0.05 mg/kg, fentanyl 1 µg/kg, lidocaine 1 mg/kg. Induction of anesthesia was achieved with an infusion of propofol 1-2 mg/kg and vecuronium bromide 0.6 mg/kg and after 2 to 3 minutes participants were intubated with the appropriate tube size. Anesthesia was maintained with an infusion of remi fentanyl (0.05 - 1 µg/Kg/min), with oxygen (O2) in air with desflurane.

    Outcome Measures

    Primary Outcome Measures

    1. Thiol / Disulfide Balance [between the start of surgery and the end of surgery (approximately 1 hour)]

      Oxidative stress marker, that shows dynamic thiol-disulphide homeostasis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    (American Society of Anesthesiologists) ASA Classification I - II controlled hypotensive anesthesia applied septoplasty operations

    Exclusion Criteria:

    Patients with uncontrolled hypertension, Diabetes Mellitus cerebrovascular disease, coagulopathy, morbid obesity ((BMI ≥35) and those with renal disease will not be taken

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Recep Tayyip Erdogan University Training and Research Hospital

    Investigators

    • Principal Investigator: Leyla Kazancıoğlu, Asst. Prof., Recep Tayyip Erdoğan University Medical School Department of Anesthesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leyla Kazancıoğlu, Assistant Professor, Recep Tayyip Erdogan University Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03501563
    Other Study ID Numbers:
    • 2018/63
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Apr 19, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Leyla Kazancıoğlu, Assistant Professor, Recep Tayyip Erdogan University Training and Research Hospital
    hypotensive anesthesia
    thiol / disulfide
    oxidative stress markers
    septoplasty

    Study Results

    No Results Posted as of Apr 19, 2018