Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time that BIS range remains within 45 and 65 after a stepwise TCI titration
研究概览
简要总结
The purpose of this study is to determine if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration required for maintenance of the general anesthesia, with propofol and remifentanil, in adult populations older and younger than 65 years of age.
详细描述
Introduction: Currently, propofol is the most widely used intravenous anesthetic drug that is able to provide a safe general anesthesia. Propofol can be administered by using different techniques including target controlled infusion (TCI). The ability to maintain the pharmacological conditions after achieving a predetermined clinical effect is one of the major advantages of this technique. Although the use of TCI devices has increased in common clinical practice, whether or not all patients are suitable for TCI remains unclear. Pharmacological models were created based on information from healthy volunteers which may not apply for specific clinical conditions resulting either in over- or sub-dosed when using certain drugs.
It is not only individual variability in the pharmacokinetic (PK) parameters of the anesthetic that is a clinical problem, but it is also the pharmacodynamic variability. A previous study showed up to 6 times the inter-individual difference among young volunteers in loss of consciousness (LOC) and return of consciousness (ROC). In addition, greater differences may be found in the elderly.
Inaccurate general models require the anesthetic team to manually tailor medication requirements for each individual based on the desired therapeutic effect.
The purpose of this study is to evaluate if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), assessed by clinical and electroencephalographic parameters, allows for an accurate estimation of the effect concentration required for hypnosis titration and maintenance of the general anesthesia, in adult populations older and younger than 65 years of age.
General Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 20 years old.
- •Scheduled to undergo elective surgery of minor or medium complexity under general anesthesia.
- •Regarding cognitive function: subjects will be considered with enough cognitive function if they are able to read and understand the medical history form by properly answering medical questions during the preoperative anesthesia assessment and being also able to sign the informed consent form.
排除标准
- •Pregnancy.
- •Obesity (BMI >30).
- •Patients taking benzodiazepines or other central nervous system action drugs.
- •Subjects with psychiatric disorders with or without treatment.
- •Allergies or any adverse reaction to propofol or any of its components (egg lecithin).
研究组 & 干预措施
Group 1
Patients < 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml.
干预措施: Propofol (Drug)
Group 1
Patients < 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml.
干预措施: Remifentanil Hydrochloride (Drug)
Group 2
Patients ≥ 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml.
干预措施: Propofol (Drug)
Group 2
Patients ≥ 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS <40 or >65 propofol target concentration will be modified by 0,3 mcg/ml.
干预措施: Remifentanil Hydrochloride (Drug)
结局指标
主要结局
Time that BIS range remains within 45 and 65 after a stepwise TCI titration
时间窗: A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached)
TCI Effect Site Concentration achieved at LOC, depth of anesthesia will be recorded with BIS bilateral sensor
次要结局
- Time for loss of consciousness(Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response)
- Effect Site Concentration required for loss of consciousness(Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved.)
研究者
Hernan Boveri
MD
Hospital Italiano de Buenos Aires