Endothelial DysfunctionNCT06515028
Effects of Anesthesia Technique on Endothelial Function
A study testing Group GA and Group IB in people with Endothelial Dysfunction and Ischemia Reperfusion, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endothelial Dysfunction, Ischemia Reperfusion, Oxidative Stress
- What is being tested?
- Group GA and Group IB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for upper extremity surgery using a pneumatic tourniquet
- American Society of Anesthesiologists (ASA) physical status classification I
Who cannot join
- 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
Show all 10Show fewer
- Liver/kidney dysfunction
- Pregnant or breastfeeding women
- History of substance and tobacco use
- History of extremity ischemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Bagcilar Education and Training Hospital
Istanbul
About this study
Official title: 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.
Read the 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
- Being tested
- Group GA, Group IB
- Keywords
- endothelial dysfunction, ischemia reperfusion, oxidative stress, infraclavicular block, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group GAProcedure or surgery
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 IBProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group GA: general anesthesia | Active comparator | Group GA Receives: Procedure: Group GA |
| Group IB : infraclavicular block | Active comparator | Group IB Receives: Procedure: Group IB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
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.
Measured: before anesthesia (T0), 1 minute before (T1), 5 minutes after (T2), and 20 minutes after deflation of the tourniquet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start25 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sezen Kumaş Solak, Bagcilar Training and Research Hospital
- Investigators
- SEZEN KUMAS SOLAK, Principal investigator, Bagcılar Training Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515028
- Sponsor's protocol ID
- Bagcılar2
- Status last verified
- May 2026
- First submitted
- 10 Jul 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data
Publications
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.
PubMed 22465624Gourdin 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.
PubMed 19412112Vlachopoulos 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.
PubMed 26117398
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of General Anesthesia and Infraclavicular Block Applications on Oxidative Stress and Endothelial Dysfunction in Upper Extremity Surgeries
- ClinicalTrials.gov ID
- NCT06515028
- Acronym / sponsor ID
- Bagcılar2
- Keywords
- endothelial dysfunction, ischemia reperfusion, oxidative stress, infraclavicular block, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group GA: general anesthesia | Active comparator | Procedure: Group GAGroup GA |
| Group IB : infraclavicular block | Active comparator | Procedure: Group IBGroup IB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for upper extremity surgery using a pneumatic tourniquet
- American Society of Anesthesiologists (ASA) physical status classification I
Key exclusion criteria (10 listed)
- Under 18 or over 65 years of age
- Hypertension
- Diabetes mellitus
- Malignancy
- Cardiovascular disease history (congestive heart failure, myocardial infarction, venous thrombosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group GAAnesthesia 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. | Procedure or surgery | Group GA: general anesthesia |
| Group IBinfraclavicular 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. | Procedure or surgery | Group IB : infraclavicular block |
Primary outcome
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
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 22465624Rosenfeldt 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.
- Background: PubMed 19412112Gourdin 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.
- Background: PubMed 26117398Vlachopoulos 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.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEZEN KUMAS SOLAK principal investigator
Bagcılar Training Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group GA and Group IB in people with Endothelial Dysfunction and Ischemia Reperfusion, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.