The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Median absorption of glycine (10th-90th centile)
研究概览
简要总结
This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.
详细描述
As a minimally invasive procedure, operative hysteroscopy has gained popularity in the past two decades and became a standard surgical treatment for abnormal uterine bleeding unresponsive to medical management. Despite its increasing use, little information is known on the predictors of its potential complications. The absorption of glycine has been reported as the most common complication of this procedure and it remains an unpredictable complication that may lead to life-threatening conditions.
This randomized controlled trial is conducted in two centers: a tertiary care center and in a community hospital over a period of 18 months. This study aimed to compare two types of anesthesia on the absorption of glycine in operative hysteroscopy. Eligible patients undergoing operative hysteroscopy for abnormal uterine bleeding are randomized in two groups: group general anesthesia and group local anesthesia with sedation.
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
- None
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
- 否
入选标准
- •Abnormal uterine bleeding with clinical indication for operative hysteroscopy according to an obstetrician-gynecologist.
- •American Society of Anesthesia (ASA) class 1 or 2
排除标准
- •Any contraindications to hysteroscopy (suspicion of pelvic or vaginal-cervical infection, severe hemorrhage, pregnancy, suspicion of neoplasia and previous uterine perforation)
- •ASA class 3 or more
- •Women who had a previous endometrial resection
- •Diabetic patients
- •Women requiring a predetermined type of anesthesia because of a specific medical condition
结局指标
主要结局
Median absorption of glycine (10th-90th centile)
时间窗: The absorption of glycine is measured between time of the introduction of the resectoscope and its final withdrawal. Assessed between 1 minute and 20 minutes after the end of surgery
The primary outcome is the median absorption of glycine (10th-90th centile). The glycine absorption is measured by an automated surgical irrigator (tandem canister: Equimat and Endomat; Karl Storz Endoscopy, Tuttlingen, Germany) and it represent the difference between the input and the output of glycine used for the irrigation of the uterine cavity.
次要结局
- Patient's satisfaction towards the type of anesthesia(Assessed on postoperative day one. In average 24 hours after surgery.)
- Absorption of glycine greater than 1000 mL(The absorption of glycine is measured between time of the introduction of the resectoscope and its final withdrawal. Assessed between 1 minute and 20 minutes after the end of surgery)
- Discontinuation of surgery because of excessive absorption.(Assessed between 1 minute and 20 minutes after the end of surgery)
- Difference of natremia pre and post-procedure(Assessed the same day of surgery (no more than 6 hours after surgery))
- Postoperative severe hyponatremia(Assessed the same day of surgery (no more than 6 hours after surgery))
- Quality of life and recovery(Assessed on postoperative day one. In average 24 hours after surgery.)