Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- propofol consumption
研究概览
简要总结
The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.
详细描述
Women will be consecutively allocated into one of the following two groups using a 1:1 ratio in order to avoid any potential source of bias.
Group DEX: women will receive dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of procedure. At that time point, both total volume (ml) and dose (γ) of dexmedetomidine administered will be recorded.
Group MZM: women will receive remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min και midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. At that time point, both total volume (ml) and dose (γ) of remifentanil administered will be recorded.
In both groups, in case of non-co-operation of the woman (e.g. kinetic response), propofol will be given as a bolus rescue dose as follows: the 1st rescue dose will be 1mg/kg while all the next doses will be 0.5 mg/kg. At the end of the procedure, the number of rescue doses and the total rescue dose (mg) of propofol given will be recorded.
Intraoperative monitoring will include ECG, noninvasive blood pressure, SpO2, EtCO2 and depth of sedation using BIS values and ΟΑSS scale. Also, adverse effects such as hypotension, bradycardia, nausea & vomiting, rigidity, airway obstruction, and need for bag-mask ventilation will be recorded. The use of vasoactive drugs will also be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients between 25 and 45 years old that do not meet any of the exclusion criteria
排除标准
- •patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction
结局指标
主要结局
propofol consumption
时间窗: from the beginning to the end of the transvaginal oocyte retrieval procedure
difference \>30% in propofol consumption
次要结局
- airway obstruction(during the procedure)
- need to ventilate by mask(during the procedure)
- number of oocytes retrieved(up to 3 weeks after starting ovarian stimulation treatment)
- fertilization rate(up to 3 weeks after starting ovarian stimulation treatment)
- positive pregnancy test(up to 3 weeks after transvaginal oocyte retrieval)
- Live birth(up to 24 weeks after starting ovarian stimulation treatment)
- BIS score(assessed every 5 minutes during transvaginal oocyte retrieval procedure)
- presence of bradycardia (heart rate less than 50 bpm)(during the procedure)
- percentage of mature oocytes(up to 3 weeks after starting ovarian stimulation treatment)
- embryo quality(up to 4 weeks after starting ovarian stimulation treatment)
- clinical pregnancy(up to 12 weeks after starting ovarian stimulation treatment)
- presence of muscle rigidity(during the procedure)
- Observer's Assessment of Alertness/Sedation scale - OAA/S scale(assessed every 5 minutes during transvaginal oocyte retrieval procedure)
- hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure(during the procedure)
- dexmedetomidine consumption(from the beginning to the end of the transvaginal oocyte retrieval procedure)
- Post Hospital Discharge Score(from end of procedure to discharge from hospital, approximately 4 hours after procedure)
- remifentanil consumption(from the beginning to the end of the transvaginal oocyte retrieval procedure)
- vasoactive drug consumption(from the beginning to the end of the transvaginal oocyte retrieval procedure)
- patient satisfaction score(end of procedure)
- physician satisfaction score(end of procedure)
- presence of nausea or vomitus(from end of procedure to discharge from hospital, approximately 4 hours after procedure)
研究者
Paraskevi Matsota
Associate Professor of Anesthesiology
Attikon Hospital