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临床试验/NCT05301582
NCT05301582已完成不适用

The Ability of Tidal Volume Challenge Test to Predict Early Post- Operative Acute Kidney Injury and Intra-operative Hypotension in Laparoscopic Abdominal Surgeries. Prospective Observational Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.

研究概览

简要总结

The purpose of study is to verify the predictability of TV Chalange test during laparoscopic abdominal surgery for early postoperative AKI and intra-operative hypotension.

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详细描述

The number and scope of laparoscopic surgery are increasing. Now almost every abdominal organ seems suitable for laparoscopic surgery. Laparoscopy may be considered potentially risky because it may involve extreme changes in the patient's position, prolonged intra-abdominal insufflation and carbon dioxide (CO2) degassing, unexpected visceral damage, and difficulty in assessing blood loss. The anesthesiologist must select the appropriate anesthesia management technique, conduct proper monitoring, and be aware of potential complications. Early detection and reduction of possible intra-operative problems can prevent postoperative complications and early complications.

Laparoscopic injection of CO2 or N2O can cause cardiovascular depression . Insufflation at a high flow rate can also exacerbate cardiovascular sequelae, including hypotension and bradycardia, and cause cardiac arrest . Intra-operative hypotension caused by rapid laparoscopic inflation is caused by the vagal-mediated cardiovascular reflex caused by the rapid expansion of the peritoneum. It can also be attributed to the reduction in preload and venous return associated with the pneumo-peritoneum (PP) .

During the period of elevated intra-abdominal pressure, there are three different mechanisms of renal insufficiency, including hypercapnia caused by CO2 insufflation, elevated intra-abdominal pressure and renin-angiotensin-aldosterone system (RAAS) .

In another study, the incidence of AKI after laparoscopic abdominal surgery was 35.9%, which was higher than the previous study .

Patients with low-volume status are susceptible to AKI due to ischemic acute tubular necrosis due to renal insufficiency, and predisposed by hypotension as a pre-renal cause.

研究设计

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

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

入选标准

  • Gender both males and females
  • ASA Class I and II
  • Age 18-65 years
  • Patients undergoing elective laparoscopic surgery under general anaesthesia

排除标准

  • Kidney dysfunction
  • Cardiac arrhythmias and valvular heart disease
  • Chronic obstructive pulmonary disease
  • Right ventricular failure
  • Intracranial hypertension
  • Airway asthma or a long history of smoking
  • Those who are on NSAID for 1 week prior to surgery.

结局指标

主要结局

The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.

时间窗: Through Study Completionan average of 24 hours

The sensitivity of TVC test to predict early post-operative AKI in laparoscopic surgeries.

次要结局

  • The incidence of AKI in laparoscopic surgeries.(Through Study Completionan average of 24 hours)
  • The sensitivity of TVC test to predict intraoperative post insufflation and desufflation hypotension.(Through Study Completionan average of 24 hours)
  • The ability of (uNGAL) to predict early post operative AKI.(Through Study Completionan average of 24 hours)
  • The relationship between exposure index (the product of inflation time x intra-abdominal pressure) and early post-operative AKI.(Through Study Completionan average of 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Cairo University

研究点 (1)

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