跳至主要内容
临床试验/NCT06125665
NCT06125665招募中不适用

Impacts of Aminophylline on Perioperative Lung Mechanics in COPD Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Double Blinded Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Static lung compliance

研究概览

简要总结

The aim of this study is to evaluate the usefulness of adding aminophylline to dexmedetomidine intravenous infusion intraoperatively on oxygenation and lung mechanics in chronic obstructive pulmonary disease (COPD) morbidly obese patients undergoing bariatric surgery.

详细描述

Bariatric surgery is considered the most effective treatment for patients suffering from morbid obesity, as it results in maintained loss of weight and clear impact on the comorbidities related to obesity. However, despite the advantages of anesthesia, it can have detrimental effects on the recovery of obese patients who have a high prevalence of respiratory conditions and sleep disorders.

Obesity is usually related to other respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD). According to a meta-analysis encompassing more than 300,000 adult patients, obesity and asthma were interlinked, and as BMI increased, a higher risk of asthma was noticed.

The use of dexmedetomidine infusion in morbid obese patients was assessed by many clinical trials. They revealed that the use of dexmedetomidine has the same analgesic effect as the use of fentanyl with greater hemodynamic stability obtained with the use of dexmedetomidine. Dexmedetomidine has the advantage of having no respiratory depressant effect. Also, it has an amnestic effect. Dexmedetomidine does not affect the sleep pattern and maintains the airway patency.

Aminophylline is a compound of theophylline with ethylenediamine and most common uses in the airway obstruction such as asthma and COPD. primarily for its bronchodilating and central nervous stimulating effects. However, emprical evidence suggests that aminophylline, as an adenosine antagonist, can improve the recovery time from general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 60 years.
  • Patients scheduled for laparoscopic bariatric surgery not exceeding three hours under general anesthesia.
  • American Society of Anesthesiologists (ASA) class II to III.
  • Patients who had no previous abdominal surgery.
  • Patients with a body mass index (BMI) greater than 40 kg/m2and suffered obstructive lung disease diagnosed by pulmonary function tests (; forced vital capacity (FEV1\FVC) < 70%).
  • Patients who are psychologically normal.

排除标准

  • Patients who refuse to participate.
  • Those with arrhythmia or receiving anti-arrhythmic medications.
  • Those with significant coexisting diseases (e.g. kidney, heart, liver).
  • Those with known allergy to any of allocated drugs.
  • Those with excessive intraoperative blood loss more than allowable amount to every patient.

研究组 & 干预措施

Aminophylline-Dexmedetomidine Group

Experimental

10 minutes after endotracheal intubation, patients will receive IV bolus of dexmedetomidine 0.5 microgm/kg Lean body weight (LBW) over 15 min, followed immediately by intravenous infusion at 0.2 microgm /kg LBW/h and IV bolus of aminophylline of 5 mg/kg based on the ideal body weight (IBW) over 30 min, followed immediately by intravenous infusion at 0.6 mg/kg IBW/h. The study solutions will be diluted in 50 ml normal saline.

干预措施: Aminophylline-Dexmedetomidine (Drug)

Dexmedetomidine

Active Comparator

10 minutes after endotracheal intubation, patients will receive IV bolus of dexmedetomidine 0.5 microgm/kg LBW over 15 min, followed immediately by intravenous infusion at 0.2 microgm /kg LBW/h. The study solutions will be diluted in 50 ml normal saline.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Static lung compliance

时间窗: Up to 90 minutes after the beginning of the drug infusion.

Static lung compliance will be calculated as: tidal volume/ \[plateau pressure - Positive end-expiratory pressure (PEEP)\] at 5 minutes after endotracheal intubation (baseline), 30 and 90 minutes after the beginning of the drug infusion.

次要结局

  • Intraoperative oxygenation(Up to 90 minutes after the beginning of the drug infusion.)
  • Dynamic lung compliance(Up to 90 minutes after the beginning of the drug infusion.)

研究者

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

Soliman Ramadan Ahmed Naser

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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