Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

April 17, 2018 updated by: Leyla Kazancıoğlu, Recep Tayyip Erdogan University Training and Research Hospital

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.

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Rize, Turkey, 53200
        • Recruiting
        • Recep Tayyip Erdogan University Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients that are controlled hypotensive anesthesia applied septoplasty operations

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thiol / Disulfide Balance
Time Frame: between the start of surgery and the end of surgery (approximately 1 hour)
Oxidative stress marker, that shows dynamic thiol-disulphide homeostasis
between the start of surgery and the end of surgery (approximately 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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