Effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries: A randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries
研究概览
简要总结
This study is about to compare the effect of metoclopramide on gastric residual volume as measured by ultrasonography in DM patients undergoing elective surgeries. All patients will be kept nil per oral for at least 8 hours before surgery. Baseline HbA1C, fasting blood sugar, duration of DM, treatment for DM, ASA-PS grade and duration of fasting in hours will be noted on arrival at the preoperative area. A wide bore intravenous line will be secured. ASA standard monitors will be attached, as well as baseline parameters will be recorded. After getting informed written consent, gastric ultrasonography will be done in right lateral decubitus position to assess the gastric residual volume -1 (GRV-1) by measuring the gastric antral cross-sectional area before administering metoclopramide or placebo.
After that, metoclopramide 10 mg (2ml) intravenous will be given to one set of patients with DM (group A), and 2 ml NS (placebo) will be given to another set of patients with DM (group B). After 30 minutes, gastric ultrasonography will be done again in right lateral decubitus position to measure the gastric antral CSA. From the CSA of the gastric antrum, we will calculate GRV-2 by the following formula described by Perlas et al.
[GRV: 27+ (14.6×RIGHT LATERAL CSA)-(1.28×AGE)}
a) Low risk: patients who have a GRV of less than 1.5mL/kg.
(b) High risk: patients who have a GRV of more than 1.5mL/kg.
Before conveying GRV findings, the anaesthesiologists responsible for intraoperative management but blinded to the group allocation will be asked about the anaesthesia and airway plan. Then these GRV values will conveyed to the anaesthesiologists. Based on these GRV values, the anaesthesiologists will decide the anaesthesia plan and airway plan (GETA or SGA). Gastric ultrasonography will again be done at the end of surgery before extubation to measure GRV-3. In patients whom the surgery has been completed will assess the post operative nausea, vomiting, regurgitation and aspiration at 6 hrs, 12 hrs and at 24 hrs.
Endpoint: Post operative nausea, vomiting, regurgitation and aspiration assessment for twenty-four hours after the completion of surgery.
Primary objective: To evaluate the effect of metoclopramide on GRV as measured by ultrasonography in DM patients undergoing elective surgeries.
Secondary objectives:
(1) To grade the aspiration risk by measuring GRV in DM patients undergoing elective surgeries.
(2) To compare post operative nausea, vomiting, regurgitation and aspiration among the two groups.
(3) To assess whether there is any change in the anaesthesia and airway plan based upon gastric ultrasonography findings
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients between 18 and 65 years of age of either gender.
- •ASA-PS 2 or 3 patients with diabetes mellitus scheduled for elective surgeries under general anaesthesia.
排除标准
- •Patients who are not willing to give consent.
- •patients with partial and total gastrectomies.
- •Patients undergoing gastro-intestinal surgeries.
- •patients who are allergic to study drug(metoclopramide) patients who have increased intracranial pressure.
- •patients who are unable to lie in the right lateral decubitus position.
- •Factors responsible for gastroparesis other than diabetes mellitus (like pregnancy, hypothyroidism, multiple sclerosis) Those who are on medications like opioids, anti-depressants, anti-cholinergics.
结局指标
主要结局
To evaluate the effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries
时间窗: gastric residual volume measured before and 30 mins after administering drug or normal saline and just before extubation also.
次要结局
- To grade the aspiration risk by measuring gastric residual volume in diabetes mellitus patients.(To compare post operative nausea , vomiting, regurgitation and aspiration among two groups.)
研究者
Dr Hari Haran N
All India Institute of Medical Sciences, Bathinda
