The Impact of the Menstrual Cycle on Injection Pain of Rocuronium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain measure
研究概览
简要总结
This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.
详细描述
Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation.
During menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception.
Different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain.
Pain perception differs during menstrual cycle.
It has been recommended that estrogens might have an influence on somatic sensory process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology Classification (ASA) I-II
- •18-45 years
- •Regular menstrual cycle
排除标准
- •Irregular menstrual cycles
- •Patients receiving hormones or drugs affecting the ovulatory cycle
- •Amenorrhea
- •Pregnancy
- •Climacteric patients
研究组 & 干预措施
Follıcular group
patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.
干预措施: Rocuronium 0,6mg/kg (Drug)
Luteal group
patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.
干预措施: Rocuronium 0,6mg/kg (Drug)
结局指标
主要结局
Pain measure
时间窗: 10 second
Tracheal intubating dose of 0.6 mg/kg of rocuronium at room temperature was injected over 10 -15 s. The patients were observed immediately if they had pain in the arm, and the response was assessed. Withdrawal movements were also assessed and scored as follows: no movements = 0, movement limited to hand = 1, movement limited to the forearm including the elbow joint = 2, and movement of the upper arm including the shoulder joint = 3
次要结局
未报告次要终点
研究者
SİNAN YILMAZ
Associate Professor
Aydin Adnan Menderes University