Clinical trial NCT06515028: Effects of Anesthesia Technique on Endothelial Function
Official title: The Effects of General Anesthesia and Infraclavicular Block Applications on Oxidative Stress and Endothelial Dysfunction in Upper Extremity Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endothelial Dysfunction
Ischemia Reperfusion
Oxidative Stress
Keywords: endothelial dysfunction
ischemia reperfusion
oxidative stress
infraclavicular block
general anesthesia
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the effects of two different anesthesia methods, general anesthesia and infraclavicular block, on oxidative stress and endothelial dysfunction in upper extremity forearm operations.This prospective study aims to determine the ideal anesthesia method for patients undergoing upper extremity forearm surgeries under tourniquet by comparing general anesthesia and infraclavicular block applications in terms of oxidative stress and ED related to ischemia-reperfusion injury.

Detailed description: Pneumatic tourniquets are commonly used in orthopedic extremity surgeries to reduce surgical trauma and blood loss. When the tourniquet is released, it leads to the release of more free oxygen radicals than under physiological conditions, resulting in ischemia-reperfusion injury, oxidative stress, and endothelial dysfunction (ED).

Endothelial dysfunction is characterized by the imbalance between vasoactive substances such as nitric oxide (NO) and endothelin, which regulate vascular tone by exerting vasodilatory and vasoconstrictive effects.During ischemia, xanthine oxidase (XO) derived from xanthine dehydrogenase is the main source of free oxygen radicals (FOR), including superoxide anion (O2-), hydrogen peroxide (H2O2), and hydroxyl anion (OH-). Superoxide anion reacts with NO to produce peroxynitrite (ONOO-), a reactive oxygen derivative. Free radicals affect unsaturated fatty acids in membranes, leading to the production of malondialdehyde (MDA), which exerts cytotoxic effects on endothelial cells. Increased production of FOR due to oxidative stress and dysfunction of antioxidant mechanisms result in protein carbonylation. Protein carbonyl groups (PC) serve as indicators of severe oxidative damage and loss of protein function

Eligibility criteria: Inclusion Criteria:

* Scheduled for upper extremity surgery using a pneumatic tourniquet
* American Society of Anesthesiologists (ASA) physical status classification I

Exclusion Criteria:

* Under 18 or over 65 years of age
* Hypertension
* Diabetes mellitus
* Malignancy
* Cardiovascular disease history (congestive heart failure, myocardial infarction, venous thrombosis)
* Cerebrovascular disease history
* Liver/kidney dysfunction
* Pregnant or breastfeeding women
* History of substance and tobacco use
* History of extremity ischemia

Primary outcomes:
measure: Effects of Anesthesia Technique on Endothelial Function with using ultrasonographic technique
timeFrame: Brachial artery FMD measurements will evaluated using ultrasonographic technique from the contralateral Measurements will be taken at three different time points: preoperatively(FMD1), 24hours postoperatively (FMD2), 6th day postoperatively(FMD3)
measure: Evaluation of the Effect of Anesthesia Technique on Endothelial Function with evaluated in the collected blood samples levels
timeFrame: before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet
Secondary outcomes:
measure: Effects of Anesthesia Technique on Endothelial Function
timeFrame: before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet
Other outcomes:
Locations:
Study officials:
affiliation: Bagcılar Training Research Hospital
name: SEZEN KUMAS SOLAK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenfeldt F, Wilson M, Lee G, Kure C, Ou R, Braun L, de Haan J. Oxidative stress in surgery in an ageing population: pathophysiology and therapy. Exp Gerontol. 2013 Jan;48(1):45-54. doi: 10.1016/j.exger.2012.03.010. Epub 2012 Mar 23.
citation: Gourdin MJ, Bree B, De Kock M. The impact of ischaemia-reperfusion on the blood vessel. Eur J Anaesthesiol. 2009 Jul;26(7):537-47. doi: 10.1097/EJA.0b013e328324b7c2.
citation: Vlachopoulos C, Xaplanteris P, Aboyans V, Brodmann M, Cifkova R, Cosentino F, De Carlo M, Gallino A, Landmesser U, Laurent S, Lekakis J, Mikhailidis DP, Naka KK, Protogerou AD, Rizzoni D, Schmidt-Trucksass A, Van Bortel L, Weber T, Yamashina A, Zimlichman R, Boutouyrie P, Cockcroft J, O'Rourke M, Park JB, Schillaci G, Sillesen H, Townsend RR. The role of vascular biomarkers for primary and secondary prevention. A position paper from the European Society of Cardiology Working Group on peripheral circulation: Endorsed by the Association for Research into Arterial Structure and Physiology (ARTERY) Society. Atherosclerosis. 2015 Aug;241(2):507-32. doi: 10.1016/j.atherosclerosis.2015.05.007. Epub 2015 May 16.