To find out cutoff change in perfusion index as a predictor of successful subarachnoid block : A prospective observation study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- 1)To assess the changes in Perfusion Index (PI) values during subarachnoid block as a predictor of subarachnoid block
研究概览
简要总结
Participants for the study will be selected based on a thorough preoperative assessment and will be scheduled for lower abdominal or lower limb surgeries. After obtaining informed consent, each participant will undergo a sensory evaluation to establish baseline sensory function. In the operating room, an 18G IV catheter will be inserted, and standard monitoring, including non-invasive blood pressure, ECG, and SpO2, will be implemented. A bolus of 0.9% normal saline will be administered to stabilize hemodynamics before the subarachnoid block. Monitoring will include a pulse oximetry probe on the non-operating limb and skin temperature measurements, with the operating room maintained at 22-24°C. Participants will receive 0.02 mg/kg IV midazolam for sedation. During the subarachnoid block procedure, participants will be positioned sitting, and a subarachnoid puncture will be performed at the L3-L4 or L4-L5 intervertebral spaces with 12.5 to 15 mg of bupivacaine administered. Perfusion Index (PI) will be recorded immediately after the needle is removed. Post-administration, PI, Mean Arterial Pressure (MAP), sensory response to a pin prick test, and motor blockade will be monitored at intervals of 2, 4, 6, 8, 10, 12, 16, and 20 minutes. Surgery will proceed only if a sensory block at the T10 level is confirmed; otherwise, general anesthesia will be used.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals aged between 18 and 70 years.
- •2.Both male and female patients are eligible.
- •3.Patients administered subarachnoid block for anesthesia.
- •4.patients classified as American society of Anesthesiologists(ASA) physical status 1 and 2.
排除标准
- •1.Patients with autonomic neuropathy.
- •2.Individuals with limb vascular abnormalities.
- •3.Subjects whose PI signal was lost during measurements are excluded from the study.
- •4.Patients with coagulation disorders.
- •5.Those categorized as ASA physical status classification 3 and 4 6.Individuals diagnosed with peripheral vascular disease.
- •7.Patients with contraindications to SAB.
- •8.Patient refusal.
结局指标
主要结局
1)To assess the changes in Perfusion Index (PI) values during subarachnoid block as a predictor of subarachnoid block
时间窗: 2min 4min 6min 8min 10min 12min 16min 20min
2) To record the conventional pin prick method to predict the success of subarachnoid block
时间窗: 2min 4min 6min 8min 10min 12min 16min 20min
3) To evaluate and compare the predictability of success of subarachnoid block by both methods.
时间窗: 2min 4min 6min 8min 10min 12min 16min 20min
次要结局
- To record haemodynamic parameters (HR, SBP, DBP & MAP) in both the groups(2min 4min 6min 8min 10min 12min 16min 20min)
研究者
Kiran Suman
All India Institute Of Medical Sciences, Bhopal