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临床试验/NCT06360666
NCT06360666Enrolling By Invitation不适用

Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia

Asst Melegnano e Martesana1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
70
试验地点
1
主要终点
Mortality

研究概览

简要总结

The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:

Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery

详细描述

BACKGROUND Laparoscopic abdominal surgery has historically required general anesthesia. However, the use of general anesthetics has neurological effects, including the risk of postoperative neurological disorders. Cognitive impairments (amnesia, cognitive delay, postoperative cognitive dysfunction, difficulty in resuming daily activities) occur in variable percentages of patients based on the type and dosage of anesthetics, duration of exposure, cerebral perfusion pressure, baseline cognitive status, and patient age. Mechanical ventilation during general anesthesia often leads to lung atelectasis, compounded by reduced diaphragmatic excursion due to laparoscopic insufflation, potentially impacting tissue oxygenation and leading to postoperative complications. General anesthetics also have negative inotropic and chronotropic effects, affecting tissue perfusion and increasing the risk of neurological and surgical complications and cardiovascular events.

The increasing complexity of surgical techniques and patient comorbidities necessitates exploring alternatives to general anesthesia, particularly for fragile patients undergoing laparoscopic abdominal surgery. Regional anesthesia techniques have been advocated to provide effective anesthesia while minimizing neurological, cardiovascular, and respiratory impacts, thereby improving clinical outcomes and functional recovery.

RATIONALE Given the significant impact of anesthesia on postoperative complications in fragile patients undergoing laparoscopic abdominal surgery, we aim to develop an anesthetic strategy that optimizes clinical and functional outcomes, especially in terms of preserving neurocognitive and respiratory function, by reducing reliance on general anesthetics. This has led us to reconsider regional anesthesia as an alternative during laparoscopic abdominal surgery.

STUDY DESIGN This is a retrospective observational cohort clinical study, monocentric, with analysis of previous months (following acquisition of study consent) and follow-up.

Each patient underwent preoperative evaluation with a standard anesthesiology visit based on national and international guidelines (SIAARTI-ERAS-ESC). Additionally, preoperative neurologic status was assessed using the Mental Test, delirium assessment with NU-Desc, and Frailty Scale. Lung ultrasound assessment was routinely performed on the day of surgery (see attached assessment scores) before the start of anesthesia procedures and again 2 hours after surgery completion. Patients were sedated with non-GABAergic anesthetics, targeting RASS 0/-2.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • "ASA physical status">1 (ASA=American Society of Anesthesiologists)
  • METs<10 (MET= Metabolic Equivalent)

排除标准

  • "ASA physical status"=1
  • patients undergoing laparotomy or emergency surgery, presenting contraindications to central locoregional anesthesia execution (specifically: coagulation disorders, severe spinal malformations, known allergy to local anesthetics, severe aortic stenosis, systemic sepsis, puncture site infection)

结局指标

主要结局

Mortality

时间窗: 90 days

To determine the rate of postoperative mortality within the two patient cohorts

Morbidity

时间窗: 90 days

To determine the number of postoperative length of stay days within the two patient cohorts

次要结局

  • organ dysfunctions(90 days)
  • Surgical revisions(90 days)

研究者

发起方
Asst Melegnano e Martesana
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Davide Vailati

MD, Anesthesiologist, Principal Investigator

Asst Melegnano e Martesana

研究点 (1)

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