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临床试验/NCT04290026
NCT04290026Unknown早期 1 期

Ultrasound Assessment of the Effect of Metoclopramide Versus Granisetron on Gastric Volume in Patients Undergoing Caesarean Section

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
90
试验地点
1
主要终点
1. The size of the cross-sectional antral area

研究概览

简要总结

Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section study

详细描述

Nausea and vomiting in the perioperative period are common sequelae during abdominal operations, with variable rates up to 80%, as reported in the literature. Perioperative nausea and vomiting associated with pregnancy originate from multiple factors. Pregnancy hormones induced lowering of the lower oesophageal sphincter tone, elevated gastric pressure by the effect of gravid uterus, hypotension, manipulation of the uterus during the operation that leads to visceral stimulation, and the use of opioids; which represent some of the proposed causative factors .

There is a lack of cost-effectiveness and consensus about prophylactic antiemetic use before abdominal surgeries. However, there is enough data reported in the literature that suggests the prophylactic use of antiemetic therapy for patients undergoing cesarean section (CS) under either general or regional anesthesia and as rescue medication for the treatment of episodes of intraoperative and postoperative nausea and vomiting.

Metoclopramide studied intensively as one of the best premedications in patients undergoing abdominal surgeries, especially in the obstetric population. It has a favorable effect on reducing the gastric fluid volume during the operation and consequently decreasing the incidence of aspiration pneumonia .

Granisetron is a selective 5-HT3 receptor antagonist with little or no affinity for other serotonin receptors is classified as drug group B in pregnant patients and approved by the FDA (Food and Drug Administration) for the treatment of post-operative nausea and vomiting in adults . 5-HT3 receptor antagonists exert appropriate clinical efficacy and low incidence of adverse drug reactions. In comparison with ondansetron, granisetron is a more potent antagonist with a longer duration of action .

Different methods such as paracetamol absorption, polyethylene glycol dilution (PEG), and electric impedance tomography (EIT) suggested as methods for visualizing the structure, volume, and time to the emptying of the stomach. Gastric scintigraphy remains the gold standard for such detections . However, scintigraphy is discouraged in routine clinical settings and pregnant patients owing to the risk of radiation exposure, low cost-effectiveness, and intricate instrumental setups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Age :18-45
  • Informed consent

排除标准

  • women who have a history of :
  • diabetes mellitus
  • hypertension
  • preeclampsia
  • neurological and psychological disorders
  • renal or hepatic diseases
  • chronic Gerd
  • refusal to provide informed consent

研究组 & 干预措施

metoclopramide versus granisetron

Active Comparator

Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section: A randomized, double-blind, placebo-controlled study

干预措施: metoclopramide versus granisetron (Drug)

结局指标

主要结局

1. The size of the cross-sectional antral area

时间窗: Immediately after the procedure

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

  • The incidence of post operative nausea or vomiting and the effects on the hemodynamic status(1day)

研究者

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

Mohamed Ahmed

Assistent lecturer

Assiut University

研究点 (1)

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