此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery

2017年5月3日 更新者:Pathomporn Pin on, M.D.、Chiang Mai University

Intraoperative Intravenous Dextrose Administration and the Incidence of Nausea and Vomiting After the Gynecologic Laparoscopic Surgery A Randomized Double-Blinded Controlled Study

The investigators tested the hypothesis that administration of intravenous dextrose as a maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same dose.

A prospective randomized double blinded controlled study was conducted. Eighty six participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44). The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after surgery.

研究概览

详细说明

Postoperative nausea and vomiting (PONV) is a major complication in laparoscopic gynecologic surgery. There are limited data and conflicting results from previous studies related to the types of intravenous fluid and a reduction in PONV. The incidence of nausea is slightly greater than the incidence of vomiting (50% vs. 30%). General anesthesia increased the likelihood of PONV 11 times compared with other types of anesthesia. Laparoscopic surgery can further increase the incidence of PONV to 80%.Identified risk factors of PONV included female, history of motion sickness, nonsmoking, younger age, general anesthesia, use of volatile anesthetics and nitrous oxide, opioids, duration of anesthesia, and types of surgery (cholecystectomy, laparoscopic, gynecological). Adequate intravenous fluid hydration is another effective strategy for reducing the baseline risk for PONV (Evidence A2). Previous studies showed that there was no difference in efficacy between crystalloids and colloids when similar volumes were used in surgeries associated with minimal fluid shifts. While liberal intravenous fluid administration, such as 30 ml/ kg of sodium lactate solution, reduced the incidence of PONV after gynecologic laparoscopy compared to another group receiving 10 ml/kg of sodium lactate solution, this strategy did not reduce the PONV in other surgical procedures such as thyroidectomy. Among crystalloid solutions, results from previous studies were conflicting regarding the benefit of intravenous dextrose administration to reducing the PONV. Hypovolemia with and without hypoglycemia after overnight fasting were believed to exacerbate PONV.

The investigators hypothesized that intraoperative infusion of dextrose solution could reduce the incidence and severity of PONV. The investigators proposed to determine the relationship between types of fluid administration and antiemetic requirement and serum glucose in paricipants scheduled for the gynecologic laparoscopy.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • ASA I-II
  • elective surgery
  • Gynecologic laparoscopic surgery
  • give informed consent

Exclusion Criteria:

  • pregnancy
  • DM
  • congestive heart failure

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:normal saline solution
The patients received normal saline solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
The patients received NSS during surgery
其他名称:
  • 生理盐水
有源比较器:dextrose solution
The patients received dextrose solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
The patients received 5%D/N/2 during surgery
其他名称:
  • 5% dextrose in half strength saline solution

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
the incidence and severity of postoperative nausea and vomiting
大体时间:24 hour after surgery
Bellville score assessment
24 hour after surgery

次要结果测量

结果测量
措施说明
大体时间
Antiemetic drug requirement
大体时间:24 hour after surgery
nausea and vomiting drugs requested by the patients
24 hour after surgery
serum glucose
大体时间:2 hour after surgery
DTX was assessed
2 hour after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pathomporn Pin-on、Chiang Mai University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年9月30日

初级完成 (实际的)

2015年9月28日

研究完成 (实际的)

2015年10月31日

研究注册日期

首次提交

2017年4月30日

首先提交符合 QC 标准的

2017年4月30日

首次发布 (实际的)

2017年5月4日

研究记录更新

最后更新发布 (实际的)

2017年5月8日

上次提交的符合 QC 标准的更新

2017年5月3日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • ANE-2557-02323
  • 2519-04-17 (其他标识符:Asian Biomedicine)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅