Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Heart rate (HR)
研究概览
简要总结
The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil.
详细描述
Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, the hypnotic effects are often synergistic. Propofol is associated with hypotension and bradycardia and used together with remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic effects.
Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 microg/kg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 03Prop). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women
- •Age 18-50 years
- •Gynecological procedures
- •General anesthesia
排除标准
- •Pre-existing hypertension
- •Diabetes for several years
- •Ischemic heart disease
- •Cerebrovascular disease
- •Heart valve disease
- •Verified cardiac arrhythmia
- •Kidney or hepatic disease
- •Hypersensitivity for soya, eggs or peanuts
- •Pregnancy
- •Poor health state
- •Illicit substance use
- •BMI <20 or >35 kg/m2
- •SBP >150 mmHg
- •HR >100 beats/min
研究组 & 干预措施
High Propofol
High Propofol induction dose
干预措施: Propofol (Drug)
Low Propofol
Low Propofol induction dose
干预措施: Propofol (Drug)
结局指标
主要结局
Heart rate (HR)
时间窗: The first 7.5 minutes during induction of general anesthesia
Relative change of HR (beats)
Systolic blood pressure (SBP)
时间窗: The first 7.5 minutes during induction of general anesthesia
Relative change of SBP (mmHg)
次要结局
- Stroke Volume (SV)(The first 7.5 minutes during induction of general anesthesia)
- Cardiac Output (CO)(The first 7.5 minutes during induction of general anesthesia)
- Systemic Vascular Resistance (SVR)(The first 7.5 minutes during induction of general anesthesia)
研究者
Gunnar Helge Sjøen
Overlege, anestesi
Helse Fonna
