Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

NCT03501563 | Unknown DMC

• 1 other identifier: 2018/63
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Septum Deviation

Keywords

hypotensive anesthesia; thiol / disulfide; oxidative stress markers; septoplasty

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients that are controlled hypotensive anesthesia applied septoplasty operations

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53200, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Study Officials

• Leyla Kazancıoğlu, Asst. Prof.

  Recep Tayyip Erdoğan University Medical School Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Kazancıoğlu, Asst. Prof.

CONTACT

+90 464 2123009; leylahotaman@hotmail.com

Şule Batçık, Asst. Prof.

CONTACT

+90 464 2123009; drsulebatcik@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 18, 2018
• Study Start: April 5, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)