The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
There are suggestions from experimental pain studies that pain perception in patients with severe obesity differs compared with individuals with lower BMI values, with a tendency for patients with severe obesity to be hypoalgesic - that is, to have reduced numerical pain scores to a variety of painful stimuli. That finding could be related to: associated reduced cognitive function (complex attention, verbal and visual memory, and decision making) in severe obesity.
The purpose of this study is to determine differences between females' pain levels whether they are obese or non-obese, during different menstrual phases (premenstrual, postmenstrual and menopausal phases) through propofol injection pain given for induction of GA
详细描述
- Study population Ninety patients, 18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective gynecological surgery, will be enrolled in this prospective observational study.
- Patients' recruitment Patients will be recruited after admission to the hospital, same day they scheduled for surgery. All women who will meet inclusion criteria and gave written informed consent for participation in the study will be enrolled.
Patients will be divided into 2 groups according to BMI levels: Non obese (whether normal weight or overweight) = Group "NO" and obese = Group "O". Normal weight is defined as BMI 18.5-24.9, overweight as BMI 25.0-29.9 and obesity as BMI ≥ 30. [8] This study is a single blind study, where patients are aware of their menstrual status but supporting examiner is not aware of the patients' menstrual status.
Patients will be instructed on a vertical VAS 0-10 cm where (0) is marked as no pain and (10) is marked as the worst pain ever felt After standard anesthesia monitoring, Administration of oxygen will be performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose will be injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients will be observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset will be documented (to differentiate early or late type of pain).
Another anesthesiologist, who is unaware of the study groups, will assess the intensity of pain after propofol injections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years - 65yor older,
- •physical status ASA I&II
排除标准
- •irregular menstrual cycle,
- •those who received hormonal therapy for any cause,
- •on oral contraceptive pills,
- •breast feeding,
- •pregnant,
- •history of total abdominal hysterectomy and/or bilateral salphingo-opherectomy.
- •patients who had difficulty in understanding the visual analogue scale (VAS)/ pain scoring systems,
- •renal or hepatic insufficiency,
- •anticipated difficult tracheal intubation, and
- •hypersensitivity to the study drugs.
- •Also, patients on antidepressants and analgesics
研究组 & 干预措施
Non obese
Non obese (whether normal weight or overweight) = Group "NO"
干预措施: Non obese (Drug)
Obese
obese = Group "O"
干预措施: Obese. (Drug)
结局指标
主要结局
VAS score
时间窗: immediately after injection
Incidence \& severity of propofol injection pain (Mild pain was defined as VAS score 0-3, Moderate as VAS score 4-6, Severe as VAS score 7-10).
次要结局
- Type of Propofol injection pain, early or late (after 10 seconds)(after 10 seconds)
- Hemodynamic variables(till 5 minutes after tracheal intubation)
- Rate pressure products(till 5 minutes after tracheal intubation)
研究者
Raham Hasan Mostafa, MD
Assistant Professor of Anesthesia
Ain Shams University