COMPARISON OF THE EFFECTS OF GENERAL ANESTHESIA AND INTERSCALENE BLOCK ON BRACHIAL ARTERY BLOOD VOLUME FLOW, PERFUSION INDEX AND PERIPHERAL REGIONAL TISSUE OXYGENATION IN UPPER EXTREMITY SURGERY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Brachial Artery Flow Volume
研究概览
简要总结
This study will aim to compare the effects of two different anesthesia techniques-general anesthesia (GA) and interscalene brachial plexus block (ISB)-on forearm tissue oxygenation in patients undergoing shoulder surgery. A total of 49 patients aged 18 to 65 will be enrolled. After standard monitoring, a pulse oximeter will be placed on the second finger of the operative limb, and a regional oxygen saturation (rSO₂) sensor will be applied to the forearm to measure the perfusion index (PI) and rSO₂.
Brachial artery parameters will be evaluated using ultrasound imaging approximately 2-3 cm proximal to the antecubital fossa. Patients will be assigned to either the GA group (Group 1) or the ISB group (Group 2). Mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO₂), flow volume (FV), brachial artery diameter (BAD), and near-infrared spectroscopy (NIRS) variables (rSO₂, ΔcHbi, ΔO₂Hbi, ΔHHbi), along with PI values, will be recorded at baseline (before the procedure) and at 10, 20, 30, and 60 minutes following the completion of the block procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the individual performing outcome measurements (MAP, HR, SpO₂, NIRS, PI, and ultrasound-based parameters) will be blinded to group assignments to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •Undergoing shoulder surgery between December 15, 2023, and March 15, 2024
- •Provided written informed consent to participate in the study
排除标准
- •Patients who refuse to participate in the study
- •American Society of Anesthesiology (ASA) physical status classification of III or IV and above
- •Contraindications to interscalene block
- •Inability to cooperate during the procedure
- •Patients with renal failure
- •Patients with hepatic failure
- •Pregnant or breastfeeding women
研究组 & 干预措施
Group GA
Participants in this group will receive general anesthesia using standard induction and maintenance protocols. No regional block will be administered. Hemodynamic parameters, brachial artery flow, and tissue oxygenation values will be monitored throughout the procedure.
干预措施: General Aneasthesia (Procedure)
Group ISB
Participants in this group will receive an ultrasound-guided interscalene brachial plexus block as the sole anesthesia technique. No general anesthesia will be administered. Hemodynamic parameters, brachial artery flow, and tissue oxygenation values will be monitored throughout the procedure.
干预措施: Interscalene block (Procedure)
结局指标
主要结局
Brachial Artery Flow Volume
时间窗: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Flow volume of the brachial artery will be measured using ultrasound to evaluate changes in blood flow during and after anesthesia.
次要结局
- Forearm Tissue Oxygenation and Perfusion(Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.)
- Perfusion Index (PI)(Baseline, and at 10, 20, 30, and 60 minutes after block completion.)
研究者
halil kızılışık
Anesthesiology and Reanimation Specialist, M.D.
Sakarya University