Effects of Anesthesia Technique on Endothelial Function

May 2, 2026 updated by: Sezen Kumaş Solak, Bagcilar Training and Research Hospital

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

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye)
        • SBU Bagcilar Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group GA: general anesthesia
Group GA
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.
Active Comparator: Group IB : infraclavicular block
Group IB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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)
before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SEZEN KUMAS SOLAK, Bagcılar Training Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not share individual patient data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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