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临床试验/CTRI/2025/07/091295
CTRI/2025/07/091295尚未招募不适用

Evaluation Of Gastric Residual Volume Emptying time following Carbohydrate Drink Intake Using Ultrasonography in Adult Patients Undergoing Laparoscopic Cholecystectomy - An Observational Study

AIIMS Guwahati1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年7月30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
55
试验地点
1
主要终点
Quantify absorption rate (time to Gastric Residual Volume less than 1.5 mL per kg or Perlas Grade 0 and 1) following complex carbohydrate ingestion

研究概览

简要总结

This observational study aims to evaluate the gastric emptying time of a commercially available complex carbohydrate drink in adult patients undergoing elective laparoscopic cholecystectomy using point-of-care ultrasonography. Conducted at AIIMS Guwahati, the study will recruit 55 patients aged 18 to 65 years (ASA I or II) and assess gastric residual volume (GRV) at serial time intervals after ingestion of 296 mL of the drink, until a safe threshold (GRV less than 1.5 mL per kg or Perlas Grade 0 or 1) is reached. The study will also analyse gastric antral cross-sectional area (CSA) in different positions, and track postoperative symptoms like nausea and vomiting. The findings aim to determine whether current ERAS guidelines on preoperative carbohydrate loading are appropriate for Indian patients, especially those with potential for delayed gastric emptying due to underlying metabolic or gallbladder-related factors.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Cholelithiasis Patients Scheduled for Laparoscopic Cholecystectomy
  • ASA PS I/II
  • 18-65 years old
  • Fasted Patients 8hrs for solids and 2 hrs for clear liquids.

排除标准

  • Patients with known gastric pathologies
  • Uncontrolled Diabetes Mellitus
  • Refusal to consent
  • Previous history of surgeries on the oesophagus or stomach
  • Pregnant patients
  • Obese patients with a BMI more than 30 kg per sq m
  • Patients who cannot lie down in the right lateral decubitus position.

结局指标

主要结局

Quantify absorption rate (time to Gastric Residual Volume less than 1.5 mL per kg or Perlas Grade 0 and 1) following complex carbohydrate ingestion

时间窗: T0 As soon as the patient is shifted to the preoperative area | T1 immediately after ingesting a Complex Carbohydrate Drink | T2 to Tx at subsequent intervals until the Gastric Residual Volume reaches less than 1.5ml per kg.

次要结局

  • 1. To compare the Gastric Antral Cross sectional area in Supine and RLD positions(T0 As soon as the patient is shifted to the preoperative area)
  • 2. To calculate GRV per kg and GRV per BSA(T0 As soon as the patient is shifted to the preoperative area)
  • To assess Perlas Grade Distribution, hunger or thirst or satisfaction (NRS scale), and postoperative symptoms (nausea and vomiting) among the cohort(T0 As soon as the patient is shifted to the preoperative area)

研究者

发起方
AIIMS Guwahati
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ujjawal Rathore

AIIMS Guwahati

研究点 (1)

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