Comparative analysis of incidence of atelectasis during elective laparoscopic cholecystectomy: Thoracic segmental spinal anaesthesia with isobaric levo bupivacaine versus general anaesthesia in adults
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the post operative atelectasis based on ultrasonography
研究概览
简要总结
Laparoscopic cholecystectomy is one of the most common surgical procedures performed worldwide. It has
revolutionized surgical practice by reducing morbidity and hospital stays. However, anaesthetic techniques
play a crucial role in ensuring optimal peri-operative outcomes. General anaesthesia (GA) is traditionally
used for laparoscopic procedures, but thoracic segmental spinal anaesthesia (TSSA) has emerged as a
promising alternative.
GA remains the gold standard for laparoscopic procedures, providing adequate anaesthetic depth, muscle
relaxation, and airway protection. However, GA is associated with certain drawbacks such as postoperative
nausea and vomiting (PONV), respiratory complications, hemodynamic fluctuations, and prolonged
recovery times. Thoracic segmental spinal anaesthesia may be used as an alternative for such surgeries. It is gaining
popularity due to its better safety profile and reduction in post-operative pain. Various local anaesthetics
have been used in TSSA which include hyperbaric or isobaric bupivacaine, ropivacaine, or lately levo-
bupivacaine. Along with these, various adjuvants have also found their place in the literature namely
fentanyl, dexmedetomidine, sufentanil, etc. Most of the literature has compared TSSA with general
anaesthesia establishing its significance in various thoraco-abdominal surgeries, but on searching the
literature, we did not find many studies that compared the TSSA with local anaesthetics isobaric
levobupivacaine- fentanyl for assessment of post operative atelectasis.
Hence we propose this study to compare the incidence of post operative atelectasis of isobaric
levobupivacaine-fentanyl in thoracic segmental spinal anaesthesia and general anesthesia in patients
undergoing laparoscopic cholecystectomy surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females aged 18-65 years undergoing laparoscopic cholecystectomy surgeries.
- •ASA PS- I-II patients.
排除标准
- •Patients with a history of allergy to local anesthetics Hemodynamically unstable patients, with sepsis Coagulopathy Significant liver or renal disease Patients with local site infection Patients with any spinal deformity.
结局指标
主要结局
To compare the post operative atelectasis based on ultrasonography
时间窗: Before surgery, 20 minutes in post operative period
(Modified lung ultrasound score) among the two groups
时间窗: Before surgery, 20 minutes in post operative period
次要结局
- To compare the intra-operative hemodynamic parameters among the two groups(0,1,2,3,4,5,10,15,20,25,30,40,5,60.75,90 minutes intraoperative)
- To compare the VAS scores and time for first rescue analgesia in the postoperative period among the(two groups)
- To compare the cost effectiveness among the two groups.(post operative)
- To compare the readiness of discharge from PACU to ward using Modified Aldrete score among the(two groups)
- To compare the post operative recovery based on QoR 15 score among the two groups(24 hours post operative)
研究者
Dr Ravneet Kaur Gill
Dr B R Ambedkar State Institute of Medical Sciences, Mohali