Comparison Between Dexmedetomidine and Remifentanil on the Maternal Responses to Tracheal Intubation in Severe Pre-eclamptic Patients During Caesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean blood pressure
研究概览
简要总结
Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5 % of pregnancies.
Tracheal intubation in the women with severe pre-eclampsia is usually associated with exaggerated transient increases in blood pressure, heart rate and maternal plasma catecholamine concentrations. These changes may lead to maternal cerebral oedema, haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of the haemodynamic responses to tracheal intubation in this unique group of patients is demanding for the best of both mother and foetus.
The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the haemodynamic and catecholamine responses to laryngoscopy and tracheal intubation in severe pre-eclamptics during Cesarean delivery under general anesthesia. Unfortunately, the use of 1 µg/kg doses are associated with more maternal hypotension and neonatal respiratory depression requiring resuscitation. Moreover, the use of preinduction remifentanil bolus of 0.5 µg/kg followed by a continuous infusion at 0.15-0.2 µg/kg/min is associated with significant attenuation of the maternal stress response to tracheal intubation with variable degree of neonatal depression in non-pre-eclamptic women. Whereas, the use of infusion rates of 0.1 µg/kg/min or less is less likely to produce neonatal depression.
In our previous study, we demonstrated that the preoperative administration of dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is associated with higher postoperative sedation scores.
详细描述
We hypothesize that the preoperative intravenous dexmedetomidine (0.4 µg/kg/h) and remifentanil (0.1 µg/kg/min) infusions will have comparable maternal haemodynamic responses to tracheal intubation, surgical stimulation and extubation after uncomplicated Caesarean delivery under general anesthesia in parturients with severe pre-eclampsia, without adverse neonatal effects.
Anaesthetic management will be standardized in all studied patients. Oral ranitidine 150 mg and metoclopramide 10 mg will be given the night before and on the morning of surgery, with 0.3 mol/L sodium citrate 30 mL given 15 min before induction. Magnesium sulphate will be given as a loading dose of 4 g intravenously, followed by i.v. infusion of 1g/hour for seizures prophylaxis.
Intravenous boluses of hydralazine 5 mg at 20-min intervals will be used if SAP increases above 160 mm Hg or DAP above 110 mm Hg, to keep the diastolic blood pressure at approximately 90 mmHg and the doses used will be recorded.
The studied population will be allocated randomly to one of two groups, (n = 18, in each), by drawing sequentially numbered sealed opaque envelopes containing a software-generated randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical Sciences, Isfahan, Iran), to receive either dexmedetomidine (0.4 µg/kg/h) or remifentanil (0.1 µg/kg/min) starting 20 and 5 min before induction of anaesthesia, respectively, and will be discontinued after peritoneal closure. The dexmedetomidine and remifentanil solutions looked identical.
One anaesthesiologist who is not otherwise involved in the study, will prepare the study solutions, install them in the infusion pumps, set up the dose according to the assigned randomized dose, and will mask the infusion pumps with an opaque sheet throughout the procedure to ensure the blindness of the assessors. Another anaesthesiologist who will be blinded to treatment regimen provided perioperative care. A third anaesthesiologist will collect perioperative data. All staff in the operating room will be unaware of patient allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gestational age ≥ 34 weeks
- •severe pre-eclampsia
- •symptoms of imminent eclampsia
- •Caesarean delivery
- •General anaesthesia
排除标准
- •allergy to dexmedetomidine
- •cardiac disease
- •pulmonary disease
- •hepatic disease
- •renal disease
- •neurological disease
- •neuromuscular disease
- •body mass index >35kg/m2
- •diabetes mellitus
- •coagulation disorders
- •bleeding disorders
- •Hemolysis, Elevated Liver enzymes and Low platelet count (HELLP) syndrome
- •receiving cardiovascular medications
- •receiving antipsychotic medications
- •receiving hypnotic medications
- •alcoholic
- •drug abuse
- •foetal distress
- •placenta praevia
- •abruptio placenta
- •multiple pregnancy
研究组 & 干预措施
Dexmedetomidine
dexmedetomidine intravenous infusion rate of 0.4 µg/kg/h
干预措施: Dexmedetomidine (Drug)
Remifentanil
remifentanil intravenous infusion rate of 0.1 µg/kg/min
干预措施: Remifentanil (Drug)
结局指标
主要结局
Mean blood pressure
时间窗: Changes from baseline for 60 min after delivery
Mean blood pressure
次要结局
- Heart rate(Changes from baseline for 60 min after delivery)
- Systolic blood pressure(Changes from baseline for 60 min after delivery)
- neonatal Apgar scores(from delivery to 5 minutes after that)
- Diastolic blood pressure(Changes from baseline for 60 min after delivery)
- Neurologic and adaptive capacity score(for 24 hours after delivery)
- Maternal Cortisol(from baseline for 1 hour after delivery)
研究者
Mohamed R El Tahan
Associate professor
Mansoura University