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临床试验/NCT03166228
NCT03166228已完成2 期

Hematological, Biochemical and Hemodynamic Changes During Operative Hysteroscopy Using Consecutive Distension Media

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from Baseline Systolic Blood Pressure

研究概览

简要总结

Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. This instrument was later modified to accommodate gynaecological applications. Operative hysteroscopy became popular after improvements in endoscopic technology and instruments in the 1970s and after the introduction of fluid distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been increasingly used for operative procedures

详细描述

Operative hysteroscopy has become a standard surgical treatment for abnormal uterine bleeding unresponsive to conservative medical management since it was shown as a safe and effective alternative to hysterectomy.(2,3) Monopolar resectoscope necessitates an irrigating fluid that should be a non-conductive and salt free solution such as glycine 1.5% or sorbitol 3%.(4) Physiologic irrigating fluids (e.g. saline 0.9%) are contraindicated with these instruments since electric current generated by any monopolar electro surgical unit is preferentially conducted through low impedance fluid rather than through tissue and consequently it's difficult to initiate cutting and impossible to create significant tissue coagulation with these devices The clinical drawback of non-conductive irrigating solution (e.g. glycine 1.5%) is the risk of excessive fluid absorption leading to symptomatic dilutional hyponatremia and for hypotonic solutions, hypo-osmolarity and secondary cerebral oedema as Glycine is metabolized to carbon dioxide, water and ammonia, and may lead to intra-cellular over hydration and neurotoxicity which is clinically reflected as hypoxemia, agitation, nausea and hypertension.(5).Although rare, irreversible neurologic damage and death have been reported after excessive absorption of salt free irrigating solutions during routine operative hysteroscopy(6)Theoretically, distension with 0.9% saline as a distension medium avoids most of the above mentioned risks associated with hyper absorption of non electrolytic distension media(7) However, there is no doubt that excessive absorption of normal saline can be fatal(8).

Recently , it has been suggested that the type of anesthesia could modify fluid absorption(9). General anaesthesia has been associated with less Glycine absorption than epidural anaesthesia: the latter being associated with systemic vasodilatation(9).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • In this study we will include 60 patients (age ranged from 20 to 40 years) with uterine size less than 12 weeks and cavity depth less than 12cm. Different types of intrauterine lesions (submucous fibroids of types 0, 1 and 2 with diameter less than 4 cm, polyps,septum and adhesions).

排除标准

  • Any case with the following diseases will be excluded from the study.
  • Cardiac diseases (myocardial ischemia, myocardial infarction or valve lesions).
  • Renal impairment.
  • Neurological affection.
  • Chest diseases.
  • Hepatic impairment.
  • coagulation abnormalities.
  • Patient refusal.

研究组 & 干预措施

normal saline0.9%

Active Comparator

0.9% saline distension media is used as long as diathermy is not in use

干预措施: Normal Saline 0.9% Infusion Solution Bag (Drug)

1.5% GLYCINE

Placebo Comparator

1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use

干预措施: 1.5% Glycine only (Drug)

结局指标

主要结局

Change from Baseline Systolic Blood Pressure

时间窗: data will be collected over 24 hours from the beginning of the procedure

Non-invasive blood pressure measurement by using sphygmomanometer cuff

次要结局

未报告次要终点

研究者

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

ahmed sonbaty

principle investigator

Assiut University

研究点 (1)

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