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临床试验/NCT04775212
NCT04775212Unknown不适用

Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
liver function test

研究概览

简要总结

It is designed to compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions in pediatric cancer patients

详细描述

Patients will be randomly allocated into two groups using a sealed envelope technique: desflurane group (Des group, n = 30) and sevoflurane group (sevo group, n = 30).

Anesthesia monitoring included electrocardiogram, continuous arterial and pulse oximetry, capnography, urine output, nerve stimulator, and esophageal core temperature.

Anesthesia will be induced with Propofol 2 mg/kg ,FentanyL 2 μg/kg and atracurium (0.5 mg/kg) was administered to achieve muscle relaxation before endotracheal intubation. End-tidal desflurane or sevoflurane concentrations during the induction were limited to 2 minimal alveolar concentration (MAC). Concentrations of inhalational anesthetics were measured using an anesthetic gas analyser (Datex-Ohmeda, Helsinki, Finland). For the maintenance of anesthesia, the inspired desflurane or sevoflurane concentration was carefully titrated to maintain the end-tidal concentration of 1 MAC. A constant fresh gas flow of 3 l/min (medical-grade air in oxygen to make inspiratory oxygen fraction 0.5) was used during the maintenance of anesthesia. Ventilation was controlled with a tidal volume of 7-10 ml/kg and ventilatory rate was adjusted to maintain an end tidal carbon dioxide ( CO2 )of 35-40 mmHg. to maintain intraoperative blood pressure (BP) and heart rate (HR) within 20% of preoperative values. additional Atracurium will be administered as appropriate. Nerve stimulator was used to monitor neuromuscular blockade on the right adductor pollicis. Hypotension (a drop in systolic BP to the extent of 30% or more or the systolic BP being less than the preoperative values) was treated with volume replacement and, when necessary, with intravenous ephedrine in incremental doses .Bradycardia (HR < 50 beats per min) was treated with atropine if needed.

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) expressed in international normalized ratio (INR), albumin, platelet count (PLT), and hemoglobin (Hb) were analysed at preoperative period, immediately after operation, and on the 1st, 2nd, 3rd, 5th and 7th, postoperative days (PODs).

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
Single (Participant)

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age >1 year and < 12 years old.
  • Estimated time of surgeries within 1-3 hours.
  • Elevated liver enzymes less than triple folds.

排除标准

  • Patient refusal.
  • Hepatitis positive patients.
  • Raising liver enzymes.
  • Hepatic surgeries.

研究组 & 干预措施

desflurane

Active Comparator

patients to be anesthetized with desflurane

干预措施: Desflurane (Drug)

sevoflurane

Active Comparator

patients to be anesthetized with sevoflurane

干预措施: Sevoflurane (Drug)

结局指标

主要结局

liver function test

时间窗: 6 months

measuring Aspartate aminotransferase (AST)

ALT

时间窗: 6 months

measuring alanine aminotransferase (ALT)

Total bilirubin

时间窗: 6 months

measuring total bilirubin (TB)

prothrombin time

时间窗: 6 months

measuring prothrombin time (PT) expressed in international normalized ratio (INR)

Albumin

时间窗: 6 months

measuring level of albumin.

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Norma Osama Abdalla Zayed

assistant lecturer

National Cancer Institute, Egypt

研究点 (1)

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