Effects of Anesthesia Technique on Endothelial Function

NCT06515028 | Completed

• 1 other identifier: Bagcılar2
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Ischemia Reperfusion; Oxidative Stress

Keywords

endothelial dysfunction; ischemia reperfusion; oxidative stress; infraclavicular block; general anesthesia

Outcome Measures

Primary Outcomes (2)

• Effects of Anesthesia Technique on Endothelial Function with using ultrasonographic technique

  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

  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 Outcomes (1)

• Effects of Anesthesia Technique on Endothelial Function

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

Study Arms (2)

Group GA: general anesthesia

ACTIVE COMPARATOR

Group GA

Procedure: Group GA

Group IB : infraclavicular block

ACTIVE COMPARATOR

Group IB

Procedure: Group IB

Interventions

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 GA: general anesthesia

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.

Group IB : infraclavicular block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

SBU Bagcilar Education and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 22465624 BACKGROUND

• 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.

  PMID: 19412112 BACKGROUND

• 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.

  PMID: 26117398 BACKGROUND

Study Officials

• SEZEN KUMAS SOLAK

  Bagcılar Training Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 23, 2024
• Study Start: August 25, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)