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临床试验/NCT01301404
NCT01301404已完成1 期

Oral Rehydration Therapy With 10% Carbohydrate Drink for Preventing Postoperative Nausea and Vomiting (PONV) After Low Dose of Spinal Morphine in Patients Undergoing Total Knee Replacement

Mahidol University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
120
试验地点
2
主要终点
The incidence of postoperative nausea and vomiting after TKR

研究概览

简要总结

PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal approach, combining several means to minimize PONV, has found wide acceptance as a standard of care. In our hospital, most of the patients are supposed to fast after midnight The oral rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is not investigated yet. The aim of this study is to investigate the effect of preoperative oral rehydration therapy on the incidence of PONV.

详细描述

We enroll patients who are undergoing TKR under spinal anesthesia with 0.5% heavy bupivacaine 10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25% bupivacaine 20 ml.

The enrolled patients will fast after midnight and in the morning they are allowed to drink 10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10% carbohydrate drink is drunk between evening and midnight and extra water if needed in the study group. In the control group, the patients are allowed to drink until midnight. Total of water consumption between 18.00-24.00 will be recorded in both groups. In the morning, the study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. The premedications should not include sedation or GI mobility drugs. Before starting anesthesia, the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh their feeling from 0-10.

The surgery and pain therapy will be tha same in both groups and the PONV (incidence, severity and rescue therapy) at recovery room and 24 hours postoperative period will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are under going unilateral TKR, with ASA I-III who scheduled started in the morning list (before noon)

排除标准

  • History of motion sickness
  • Chronic kidney disease (CKD, creatinine > 2 mg/dl)
  • Hiatus hernia or gastro esophageal reflux
  • Patients receiving drugs that might affect GI motility such as opioids

结局指标

主要结局

The incidence of postoperative nausea and vomiting after TKR

时间窗: 24 hours

Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group

次要结局

  • Incidence of hyperglycemia during perioperative period(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manee Raksakietisak

Associate professor

Mahidol University

研究点 (2)

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