The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- RINVR Total Score
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of preoperative oral administration of 200 ml 12.5% carbohydrate solution on postoperative nausea, vomiting, and recovery in bariatric surgery patients. The intervention group received carbohydrate loading two hours before surgery. Outcomes were measured using the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI).
详细描述
This randomized controlled trial was designed to evaluate the effects of preoperative low-volume oral carbohydrate loading on postoperative nausea, vomiting, and recovery in patients undergoing bariatric surgery. A total of 105 adult patients scheduled for bariatric surgery were randomized into two groups: an intervention group (n = 53) and a control group (n = 52). The intervention group received 200 mL of a 12.5% carbohydrate solution orally two hours before surgery, while the control group followed standard preoperative fasting protocols without receiving any carbohydrate supplementation.
The primary hypothesis was that preoperative low-volume carbohydrate loading would reduce the frequency and severity of postoperative nausea, vomiting, and retching (PONV), and improve postoperative recovery. Data were collected using validated instruments including the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI). Outcomes were assessed within 24 hours postoperatively and at postoperative day 30.
Randomization was performed using computer-generated block randomization, and outcome assessment was blinded. The intervention was administered by a trained researcher, and standard postoperative nursing care protocols were applied to both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, no blinding was applied to participants or investigators. However, outcome assessors and statisticians were blinded to group allocation to reduce bias during data analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for bariatric surgery
- •ASA score ≤ IV
- •Literate in Turkish and able to provide informed consent
排除标准
- •Use of antiemetics, steroids, or opioids within 24 hours pre-op
- •Need for ICU post-op
- •Reoperation
研究组 & 干预措施
Carbohydrate Feeding Group
Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery.
干预措施: Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution) (Dietary Supplement)
Control Group
No carbohydrate solution provided; only standard fasting and care applied.
结局指标
主要结局
RINVR Total Score
时间窗: Day 1
RINVR Total Score within 24 hours postoperative
PORI Score
时间窗: Day 30
PORI Score at discharge and at 30-day follow-up
次要结局
未报告次要终点