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NCT Number: NCT06515028

Effects of Anesthesia Technique on Endothelial Function

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.

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Key information

Conditions

Endothelial Dysfunction Ischemia Reperfusion Oxidative Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU Bagcilar Education and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group GA

Procedure

Anesthesia induction will be performed preoxygenation with 3 minutes of 80% FiO2 , followed by intravenosus propofol 2-2.5 mg/kg and fentanyl 2 µg/kg. Rocuronium 0.6 mg/kg will be administered for neuromuscular blockade, followed by endotracheal intubation after 2 minutes of mask ventilation. Anesthesia maintenance will be achieved with inhalation of 2.5-3.3% sevoflurane with 50% oxygen and 50% air mixture, along with infusion of remifentanil at 0.1 micrograms/kg/min. ventilation will be performed using a volume-controlled.

Group IB

Procedure

infraclavicular brachial plexus block will be performed in supine position with the arm adducted and flexed at 90 degrees. A mixture consisting of 15 ml of 0.5% Bupivacaine, 15 ml of 2% Lidocaine, and 30 ml of saline solution will be prepared, with equal concentrations distributed into three different syringes of 20 milliliters each. The clavicular notch will be palpated, and an ultrasound linear probe covered with a sterile sheath will be positioned in the lateral sagittal plane over this area to visualize the median, lateral, and posterior cords of the brachial plexus surrounding the axillary artery. A special Stimuplex A 22G, 100 mm needle will be used for plexus anesthesia. local anesthetic injection will be sequentially performed around the posterior, median, and lateral cords under ultrasound guidance. After confirming sensory and motor block, the operation will be commenced.

Primary outcomes

  1. Effects of Anesthesia Technique on Endothelial Function with using ultrasonographic technique

    Time frame: 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)

    In this study, investigators aimed to determine the ideal anesthesia method for patients undergoing upper extremity surgeries accompanied by a tourniquet, by comparing general anesthesia and infraclavicular block methods in terms of oxidative stress and endothelial dysfunction (ED) related to ischemia-reperfusion injury. Brachial artery FMD (flow-mediated dilation ) measurements will evaluated using ultrasonographic technique from the contralateral

  2. Evaluation of the Effect of Anesthesia Technique on Endothelial Function with evaluated in the collected blood samples levels

    Time frame: before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet

    During the operation, the dorsal venous cannula in the foot was not utilized for any other purpose. The duration of surgery and tourniquet application was recorded for each group. Tourniquet pressure was set at approximately twice the systolic arterial pressure (SAP). Evaluated in the collected blood samples levels of Protein carbonyl (PC),xanthine oxidase (XO),nitric oxide (NO),malondialdehyde (MDA)

Secondary outcomes

  1. Effects of Anesthesia Technique on Endothelial Function

    Time frame: before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet

    During the operation, the dorsal venous cannula in the foot was not utilized for any other purpose. The duration of surgery and tourniquet application was recorded for each group. Tourniquet pressure was set at approximately twice the systolic arterial pressure (SAP). SAP, diastolic arterial pressure (DAP), mean arterial pressure (MAP), and heart rate (HR) values were recorded at time points T0, T1, T2, and T3.

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

The Effects of General Anesthesia and Infraclavicular Block Applications on Oxidative Stress and Endothelial Dysfunction in Upper Extremity Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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