Clinical trial NCT03501563: Effects of Hypotensive Anesthesia on Thiol Disulphide Balance
Official title: Effects of Hypotensive Anesthesia on Thiol Disulphide Balance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal Septum Deviation
Keywords: hypotensive anesthesia
thiol / disulfide
oxidative stress markers
septoplasty
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that are controlled hypotensive anesthesia applied septoplasty operations

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thiol / Disulfide Balance
timeFrame: between the start of surgery and the end of surgery (approximately 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital
Study officials:
affiliation: Recep Tayyip Erdoğan University Medical School Department of Anesthesia
name: Leyla Kazancıoğlu, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: