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临床试验/NCT00853177
NCT00853177已完成4 期

MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
77
试验地点
2
主要终点
Pain after oocyte retrieval at + 30, 60 and 120 minutes.

研究概览

简要总结

The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.

详细描述

Oocyte retrieval is a major event during in VITRO-fertilization, with or without sperm micro-injection. Initially done by laparoscopy with general anesthesia, the oocyte collection is now carried out by trans-vaginal controlled ultrasound puncture. This potential painful event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary, requires analgesia or anesthesia. General anesthesia is certainly effective in terms of collected oocytes. It remains, however, a heavy time consumer, with personal risks and distributor of anesthetic agents in blood or follicular fluid. These products could have a deleterious effect on early embryonic development or implantation. Few data are available concerning these risks in the literature. General anesthesia is still essential for pusillanimous patients or for patients with a heavy surgical past. Nitrous oxide is an inhaled gas with properties widely used in obstetric during parturition. It is regularly used during general anesthesia performed for oocyte retrieval. With a gas composed of 50% N2O and 50% O2, its main interest is to provide analgesia in a state of conscious sedation. The effects of nitrous oxide in this form had never been assessed on the clinical or biological Oocyte collection. We conducted a preliminary study to assess pain in patients receiving local anesthesia, according the current protocol. Thus, 44% of patients had severe pain (VAS> 40/100) during or just after transvaginal oocyte retrieval. In our preliminary experience, immediate or distance post-operative pain was high and we plan to evaluate the benefit of analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective, randomized and controlled study as compared with local anesthesia associated to Alprazolam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patient requiring a first or second oocyte retrieval procedure for IVR or ICSI after ovarian stimulation by gonadotrophin
  • agreement to participate to this study

排除标准

  • absolute indication for oocyte retrieval with general anesthesia
  • no agreement to participate to this study,
  • painfully known patient-not easy ovarian vaginal accessibility for monitoring or puncture
  • respiratory pathology-chronic liver, kidney pathology, immunodeficiency, -contraindication to the medications used during the protocol

结局指标

主要结局

Pain after oocyte retrieval at + 30, 60 and 120 minutes.

时间窗: immediate (at + 30, 60 and 120 minutes)

次要结局

  • Patients satisfaction at time + 120 minutes.(immediate (at + 120 minutes))
  • Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes.(immediate (at time + 120 minutes))
  • Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid.(immediate)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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