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临床试验/CTRI/2024/04/066529
CTRI/2024/04/066529尚未招募不适用

To evaluate the effect of metoclopramide on gastric reserve volume after adequate fasting (8 hours for solids, 2 hours for clear fluids) in patients undergoing gynaecological surgeries under subarachnoid block in a double blind and randomised clinical trial

Dr RPGMC Kangra at Tanda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
The primary outcome will be to observe the quantitative and qualitative change in gastric antrum as assessed by the US of gastric antrum to estimate gastric volume after standard dose of metoclopramide ie calculation of CSA in right lateral and supine position

研究概览

简要总结

this study will assess the effectiveness of preoperative injection metoclopramide on the gastric residual volume with the help of US guided assessment of gastric residual volume at baseline and 30 minutes after the drug. This study will also observe the effect of fasting duration on gastric volume

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA class I and II BMI 18.5 – 29.9 kg/m2 Mallampati I or II.

排除标准

  • 1.Patients’ refusal for SAB
  • Patients with cardiovascular or respiratory disorders, diabetes, hypertension 3.Obesity( BMI>29.9kg/m2) 4.Abnormality of upper gastrointestinal tract(GIT) and history of GIT related surgical procedures in the past 5.Use of drugs affecting gastric motility
  • Need for general anaesthesia (GA) due to partial effect of SAB 7.Any contraindication to SAB 8.Cognitive impaired patients 9.History of prolonged QT interval or neuropsychiatric illness.

结局指标

主要结局

The primary outcome will be to observe the quantitative and qualitative change in gastric antrum as assessed by the US of gastric antrum to estimate gastric volume after standard dose of metoclopramide ie calculation of CSA in right lateral and supine position

时间窗: baseline and 30 minutes after intervention

次要结局

  • 1.Incidence of complete gastric emptying(2.Incidence of episodes of intraoperative and postoperative nausea and vomiting after gynaecological surgeries correlated with Metoclopramide administration and gastric volume)

研究者

发起方
Dr RPGMC Kangra at Tanda
申办方类型
Government medical college

研究点 (1)

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