EUCTR2013-001926-25-BE进行中（未招募）不适用
Sugammadex and the diaphragm: recovery of diaphragmatic function and neuromuscular blockade
niversitair Ziekenhuis Antwerpen0 个研究点开始时间: 2013年8月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each participant must have the mental capacity to decide whether he/she takes part in the trial or not. Each participant must voluntarily give his/her written informed consent. In case a participant is physically unable to give a written informed consent, a legal representative is to perform this.
- •Each participant must be at least 18 years of age. Participants can be of either sex and of any ethnical background.
- •Each participant must meet the American Society of Anaesthesiologists class I, II or III criteria.
- •Each participant must be scheduled for intracranial surgery. During general anaesthesia rocuronium must be used as a neuromuscular blocking agent.
- •Each participant must be a suitable candidate for the rapid reversal of the neuromuscular blockade.
- •Each female participant of sexually active age and of childbearing potential must agree to the use of a medically accepted method of contraception through 7 days after the day of surgery. Postmenopausal (defined as at least 12 consecutive months without spontaneous menstrual period) women are not obliged to use contraceptives. Medically accepted methods of contraception include:
- •Condoms (male or female) with spermicidal agent.
- •Diaphragms or cervical caps containing a spermicidal agent.
- •Medically prescribed intrauterine devices (IUD’s).
- •Inert or copper-containing IUD’s.
- •Surgical sterilization (hysterectomy or tubal ligation).
- •Hormonal contraceptives. (If a dose is missed on the day of the operation, participants must follow the instructions mentioned on the package leaflet. In case of a non-oral hormonal contraceptive, an additional non-hormonal contraceptive method is to be used).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •The participant is known or suspected to have a neuromuscular disorder.
- •The participant is known or suspected to have an allergic reaction to sugammadex, rocuronium, anaesthetic and narcotic medications, or any of their
- •excipients/recipients.
- •The participant is known or suspected to have an anatomical malformation
- •impeding a proper intubation.
- •The participant is known or suspected to have a history of malignant
- •hyperthermia.
- •The participant is pregnant (or intends to become pregnant within the pre-surgical
- •period) or lactating.
- •The participant is known to have a renal insufficiency (defined as a serum
- •creatinine concentration of two times the upper limit, or a glomerular filtration rate of less than 60 ml/min, a urine output of less than 0.5 ml/kg/h for at least six hours, an estimated creatinine clearance of less than 30 ml/min).
- •The participant is known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher.
- •The participant is known to have an infection of the upper or lower airways, as diagnosed by clinical, radiographic or laboratory findings.
- •The participant is known or suspected to have congestive heart failure.
- •The participant is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained
- •The participant is obese, as defined by a body mass index of 30 kg/m2 or more.
- •The participant is known or suspected to have a major hepatic dysfunction
- •preventing his partaking in the trial (as determined by the investigator).
- •The participant has received or is scheduled to receive toremifene and/or an intravenous administration of fusidic acid within a time span of 24 hours before
- •and 24 hours after the surgery.
- •The participant is known or suspected to have any condition contraindicating the
- •administration of sugammadex, neostigmine or glycopyrrolate.
- •The participant is known or suspected to be directly involved in this study and/or is employed by or is a family member of any person employed by the
- •investigator, at the investigational site or by the sponsor.
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