跳至主要内容
临床试验/NCT04157998
NCT04157998Unknown不适用

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Patients Undergoing Cesarean Section: A Randomized, Double-blind, Cross-sectional Study"

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1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
入组人数
60
试验地点
1
主要终点
ultrasound quantitative assessment of gastric antrum cross-sectional area

研究概览

简要总结

the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia

详细描述

Since regional anesthesia has largely replaced general anesthesia, the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia .

The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml, and its pH falls below 2.5. However, the risk of aspiration significantly decreases in "fasted" outpatients. Since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis not recommended anymore. Studies suggest that metoclopramide, in combination with H2-receptor antagonists (such as cimetidine), significantly reduces the risk of postoperative emesis and aspiration pneumonitis. However, the time available for administering oral prophylaxis with such anti-emetic and anti-histaminic is too short for these medications to be effective

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women
  • age range between 20 to 38 years
  • provided informed consent to participate.

排除标准

  • patient refusal
  • associated co-morbidity as diabetes mllitus, hypertension, preeclampsia, renal or hepatic diseases
  • neurological and psychological disorders, ,
  • chronic gastroesophageal reflux diseases

研究组 & 干预措施

control

Placebo Comparator

patient receive 10 ml normal saline intravenous

干预措施: normal saline (Drug)

metoclopramide group

Active Comparator

patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%.

intravenous

干预措施: Metoclopramide 10mg (Drug)

结局指标

主要结局

ultrasound quantitative assessment of gastric antrum cross-sectional area

时间窗: 10 hours

gastric antrum cross-sectional area calculated as a function of the anteroposterior (APD) and craniocaudal diameter (CCD). Calculation of the cross-sectional area (CSA) conducted as a product of APD and CCD in square centimeters.

the gastric antrum cross-sectional area

时间窗: 10 hours

based on three grading system which was as follows: G-0: Antrum was flat and empty in a supine and right lateral position * G-1: Antrum had fluid in the right lateral position but empty in the supine position * G-2: Antrum had fluid and food in both the supine and right lateral position.

次要结局

未报告次要终点

研究者

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

Rasha Hamed

lecturer

Assiut University

研究点 (1)

Loading locations...

相似试验