Effect of oral vonoprazan versus pantoprazole on gastric fluid properties in diabetic patients undergoing elective surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The pH of gastric content will be recorded using pH meter in both the groups.
研究概览
简要总结
Pulmonary aspiration of gastric contents remains a serious perioperative complication, particularly in high-risk groups such as diabetic patients with gastroparesis. Current pharmacological prophylaxis with proton pump inhibitors (PPIs) like pantoprazole has limitations including delayed onset and variable efficacy. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), offers faster and more potent acid suppression with a single dose. This prospective, randomized, double-blind, single-centre interventional study aims to compare the efficacy of oral vonoprazan (20 mg) versus oral pantoprazole (40 mg) in modifying gastric pH and residual gastric volume (RGV) in 64 adult diabetic patients undergoing elective surgeries under general anaesthesia. Primary outcome is gastric pH; secondary outcomes include RGV (assessed by ultrasound), adverse drug events, and incidence of postoperative nausea and vomiting. Gastric content will be aspirated intraoperatively and analysed for pH and volume. The findings aim to evaluate the role of vonoprazan as a potential alternative for aspiration prophylaxis in high-risk surgical patients.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •• Diagnosed with Type 2 Diabetes Mellitus.
- •• ASA physical status one to three • Scheduled for elective surgeries under general anaesthesia.
排除标准
- •• History of gastrointestinal surgery.
- •• Known acid-peptic disorders or gastric motility disorders.
- •• Use of acid-suppressive therapy within 72 hours prior to surgery.
- •• Pregnancy or lactation.
- •• Obesity (BMI more than 35 kg per metre square) • Known renal or hepatic dysfunction.
- •• Allergy to study drugs • Patients already on PPI.
结局指标
主要结局
The pH of gastric content will be recorded using pH meter in both the groups.
时间窗: Patients will be transferred to the post-anaesthesia care unit (PACU), where they will be monitored for the incidence of postoperative nausea and vomiting (PONV) at 1 hour, 6 hours, | and 24 hours postoperatively.
次要结局
- • To compare the gastric residual volume in both the study groups.(• To evaluate any drug-related adverse events of Vonoprazan & Pantoprazole.)
研究者
Dr Tejasvi Dalla
Government Medical College and Hospital Sector 32 Chandigarh