跳至主要内容
临床试验/CTRI/2025/11/097819
CTRI/2025/11/097819尚未招募不适用

Effect of I-gel versus endotracheal intubation on perioperative gastric volume and postoperative gastrointestinal recovery in diabetic patients undergoing laparoscopic abdominal surgeries: a randomized comparative study.

Uttarpradesh University of medical sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月1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
70
试验地点
1
主要终点
Comparison of change in perioperative gastric volume using USG guided antral cross sectional area measurement in both the groups.

研究概览

简要总结

The study will begin after approval from the Institutional Ethical Committee and registration with the Clinical Trials Registry – India (CTRI). After obtaining informed consent, patients will be randomly assigned to either Group A (endotracheal intubation) or Group B (I-Gel insertion) using a computer-generated random number table and opaque sealed envelopes for allocation concealment. Preoperative assessment will include antral cross-sectional area (CSA) measurement using ultrasound. Standardized general anesthesia will be administered, and airway management will follow group allocation. Ventilation settings will be consistent across groups, and intra-abdominal pressure and Trendelenburg tilt will be maintained as per surgical needs. Data collection will include antral CSA at three time points, hemodynamic parameters, intraoperative ventilatory parameters (leak volume, leak fraction, peak and plateau airway pressures, EtCO2), and gastrointestinal recovery indicators such as time to clear fluids, light diet, flatus, and bowel movement. Gastric distension will be graded by the surgeon using a 5-point Likert scale, and postoperative complications such as nausea, vomiting, and sore throat will be recorded for 24 hours. At the end of surgery, anesthesia will be discontinued and reversal agents administered, with removal of airway devices based on adequate signs of recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • 1.patients undergoing Laproscopic abdominal surgeries 2.Body mass index between 18.5 to 24.9 kg per m2 3.American society of Anaesthesiologists physical status class 2 4.History of Diabetes mellitus for atleast 5 years or more with controlled blood sugar levels.

排除标准

  • Patient’s refusal
  • Baseline gastric volume more than 1ml per kg on the morning of surgery 3.Diagnosed cases of gastric esophageal reflux disease
  • Anticipated difficult airway
  • Chronic treatment with opioids, steroid, immunosuppresants, chemotherapy, drugs affecting gastric motility or gastric volume
  • Neurological or psychiatric conditions affecting gastric motility 7.

结局指标

主要结局

Comparison of change in perioperative gastric volume using USG guided antral cross sectional area measurement in both the groups.

时间窗: baseline (preoperative), just after securing airway, and at the end of surgery before extubation.

次要结局

  • Comparison of Postoperative gastrointestinal recovery
  • Measurement of hemodynamic parameters- heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP).(At baseline (preoperative), just after securing airway, at pneumoperitoneum, and at end of surgery before extubation.)
  • Measurement of intraoperative ventilatory parameters :Leak volume, leak fraction, Peak airway pressure, Plateau pressure, EtCO2.(Just after securing airway, at pneumoperitoneum, and at end of surgery before extubation)
  • Degree of gastric distension
  • Postoperative events

研究者

发起方
Uttarpradesh University of medical sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shreya Saxena

Uttar Pradesh University of Medical Sciences

研究点 (1)

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