跳至主要内容
临床试验/CTRI/2023/09/057875
CTRI/2023/09/057875招募中不适用

Ultrasonographic evaluation of gastric emptying time in obese and non-obese full term pregnant women planned for elective caesarean section following standardized meal.

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月10日最近更新:

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
Antral cross sectional areas at 15 & 90 minutes after ingestion of meal.

研究概览

简要总结

Pulmonary aspiration of gastric contents is a rare but serious complication in obstetric anaesthesia and is associated with significant morbidity and mortality. Obesity results in a further increase in this risk because obesity is associated with hiatal hernia and increased intra-abdominal pressure which may further decrease the gastric emptying. This has led to a stringent adoption of preoperative fasting guidelines, that is six hours following solids and two hours following clear liquids. However there are no separate guidelines for fasting in obese patients. Gastric ultrasound is a non-invasive procedure which can be easily performed at bedside and help in rapid risk assessment of the patient.

Women admitted in the maternity ward of lok nayak hospital who fulfill the inclusion and exclusion criteria will be recruited for the study. A special note will be made of the height, weight and BMI of the patients in addition to a detailed pre-anaesthetic checkup. After ensuring an adequate fasting, that is six hours for solids and two hours for clear liquids, an ultrasound examination of abdomen will be performed using the available ultrasound machine equipped with a curvilinear probe (2 to 5 MHz) after making the patient lie in semi recumbent position with head elevated to 45degree. After obtaining a baseline value the participants will be made to ingest a standardized meal(100g flavoured yogurt: 136kcal, 4,1g protein, 4.6g fat, 19.5g carbohydrates) within 5 minutes and serial ultrasounds of gastric antral cross section will be measured at different time intervals-15min/90min/120min in a standardized saggital plane passing through abdominal aorta and left lobe of liver. Similar procedure will be followed for non-pregnant volunteer group as well.

The antral cross section area will be used to measure the gastric emptying fraction at 15-90 minutes and half time to gastric emptying. The number of women with empty stomachs at 90min and 120min after ingestion of meal will also be assessed.

For statistical analysis, comparison of normally distributed continous variables between the groups will be performed using ANOVA. Nominal categorical data between the groups will be compared using Chi-squared test or Fisher’s exact test and non-normal distribution categorical variables will be compared using Kruskal Wallis test and further paired comparisons will be done using Mann Whitney U test.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • OBESE PREGNANT WOMEN: Pregnant women 18-40 years of age Body mass index ≥30kg/m2 American Society of Anaesthesiologists Grade 2 Singleton pregnancy NON-OBESE PREGNANT WOMEN: Pregnant women 18-40 years of age Body mass index <30kg/m2 American Society of Anaesthesiologists Grade 2 Singleton pregnancy NON-PREGNANT WOMEN: Non-Pregnant women 18-40 years of age Body mass index 18.5-24.9 kg/m2 American Society of Anaesthesiologists Grade 1 and Grade 2.

排除标准

  • OBESE PREGNANT WOMEN: Esophageal, duodenal or gastric medical or surgical history Obstetrical emergencies Intake of gastric motility altering drugs (e.g., metoclopramide- intake of even a single dose of drug within the last 24h) History of Diabetes mellitus >10 years Allergy to dairy and dairy products Aversion to consumption of yogurt NON- OBESE PREGNANT WOMEN: Esophageal, duodenal or gastric medical or surgical history Obstetrical emergencies Intake of gastric motility altering drugs (e.g., metoclopramide- intake of even a single dose of drug within the last 24h) History of Diabetes mellitus >10 years Allergy to dairy and dairy products Aversion to consumption of yogurt NON- PREGNANT WOMEN: Esophageal, duodenal or gastric medical or surgical history Intake of gastric motility altering drugs (e.g., metoclopramide- intake of drug within the last 24h) History of Diabetes mellitus >10 years Allergy to dairy and dairy products Aversion to consumption of yogurt.

结局指标

主要结局

Antral cross sectional areas at 15 & 90 minutes after ingestion of meal.

时间窗: Antral cross sectional areas at 15 & 90 minutes after ingestion of meal.

次要结局

  • Half time to gastric emptying(serial ultrasound measurements up to 120 minutes after ingestion of meal)
  • Gastric emptying fraction from 15-90 minutes after ingestion of meal
  • Number of women who had empty stomachs at 90 & 120 min after ingestion of test meal.(90 & 120 minutes after ingestion of meal)

研究者

申办方类型
Government medical college

研究点 (1)

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