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临床试验/NCT03955419
NCT03955419已完成不适用

Randomized Controlled Trial Comparing Preoperative Oral Carbohydrate Loading With Standard Overnight Fasting in Gynecologic Surgery.

Eunah Cho, MD2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
2
主要终点
Quality of recovery (QoR)-15 score

研究概览

简要总结

The advantage of carbohydrate loading in minimally invasive surgeries are not well established. We designed this study to evaluate whether preoperative oral carbohydrate improve postoperative recovery after laparoscopic gynecologic surgeries.

详细描述

This study will be conducted in the female adult patient scheduled for laparoscopic gynecologic surgery for benign or premalignant condition. Patients with American Society of Anesthesiologist physical status classification I-II, not pregnant or on lactation will be included. Patients with underlying disease that will delay gastric emptying (GERD, history of gastrointestinal surgery, diabetes), or contraindicated to NSAID or opioid, psychiatric or mental disorders, alcoholism, or drug abuse will be excluded.

Participants will be randomized into 2 group: the control group and the study group. Randomization will be conducted via random block with stratification generated by the http://www.randomization.com with 1:1 allocation. The sequence will be kept in opaque, sealed envelopes until the day before the study date. One investigator, not involved in the outcome assessment, opened the envelope on the day before the surgery, and allocated participants in each group.

After having regular diet until the evening before surgery, participants allocate in the control group were kept fasted from midnight until surgery. Participants in the study group will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). The participants in the study group will freely drink carbohydrate beverage starting from the evening before surgery up to 2 hours before surgery.

The postoperative quality of recovery (QoR) score, time to readiness to discharge, patient satisfaction, postoperative nausea and vomiting, change in body weight, and insulin resistance will be assessed.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 18 and 70 years American Society of Anesthesiologists physical status (ASAPS) classification I-II absence of pregnancy or lactation at the time of surgery.

排除标准

  • suspicious delayed gastric emptying such as GERD or gastrointestinal surgery metabolic disorders such as diabetes known contraindications to NSAID or opioid physically disabled severe psychiatric or mental disorders alcoholism, drug abuse

结局指标

主要结局

Quality of recovery (QoR)-15 score

时间窗: 2 days after surgery

This score measures the quality of recovery after surgery in 2 dimensions, which are the physical well-being (in 9 items) and mental well-being (6 items). Each item is rated from 0 (poor) to 10 (excellent). A sum of each score represents the QoR of the patients.

次要结局

  • time to readiness to discharge (TRD)(2 days after surgery)

研究者

发起方
Eunah Cho, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eunah Cho, MD

Clinical Assistant Professor

Kangbuk Samsung Hospital

研究点 (2)

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