Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

Nasal Septum Deviation Clinical Trial

Official title:

Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501563
• Other study ID #: 2018/63
• Status: Recruiting
• First received: April 6, 2018
• Last updated: April 17, 2018
• Start date: April 5, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2018
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Leyla Kazancioglu, Asst. Prof.
• Phone: +90 464 2123009
• Email: leylahotaman[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Septum Deviation

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Training and Research Hospital	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thiol / Disulfide Balance	Oxidative stress marker, that shows dynamic thiol-disulphide homeostasis	between the start of surgery and the end of surgery (approximately 1 hour)