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临床试验/NCT03864094
NCT03864094已完成4 期

"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo."

Helse Fonna1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Heart Rate (HR)

研究概览

简要总结

In this trial the investigators want to examine if there is any difference in hemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.

详细描述

The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.

Earlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination.

Several procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.

The hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 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 04Vaso). 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

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

Ephedrine Propofol Remifentanil

Active Comparator

Prophylactic Ephedrine

干预措施: Ephedrine (Drug)

Ephedrine Propofol Remifentanil

Active Comparator

Prophylactic Ephedrine

干预措施: Propofol (Drug)

Ephedrine Propofol Remifentanil

Active Comparator

Prophylactic Ephedrine

干预措施: Remifentanil (Drug)

Phenylephrine Propofol Remifentanil

Active Comparator

Prophylactic Phenylephrine

干预措施: Phenylephrine (Drug)

Phenylephrine Propofol Remifentanil

Active Comparator

Prophylactic Phenylephrine

干预措施: Propofol (Drug)

Phenylephrine Propofol Remifentanil

Active Comparator

Prophylactic Phenylephrine

干预措施: Remifentanil (Drug)

Norepinephrine Propofol Remifentanil

Active Comparator

Prophylactic Norepinephrine

干预措施: Norepinephrine (Drug)

Norepinephrine Propofol Remifentanil

Active Comparator

Prophylactic Norepinephrine

干预措施: Propofol (Drug)

Norepinephrine Propofol Remifentanil

Active Comparator

Prophylactic Norepinephrine

干预措施: Remifentanil (Drug)

Sodium chloride Propofol Remifentanil

Sham Comparator

NaCl Placebo

干预措施: Sodium chloride (Drug)

Sodium chloride Propofol Remifentanil

Sham Comparator

NaCl Placebo

干预措施: Propofol (Drug)

Sodium chloride Propofol Remifentanil

Sham Comparator

NaCl Placebo

干预措施: Remifentanil (Drug)

结局指标

主要结局

Heart Rate (HR)

时间窗: First 7,5 minutes from start of induction

Change in HR during induction as measured by the LiDCOplus monitoring system

Systolic Blood Pressure (SBP)

时间窗: First 7,5 minutes from start of induction

Change in SBP during induction as measured by the LiDCOplus monitoring system

次要结局

  • Stroke Volume (SV)(First 7,5 minutes from start of induction)
  • Cardiac Output (CO)(First 7,5 minutes from a start of induction)
  • Systemic Vascular Resistance (SVR)(First 7,5 minutes from start of induction)

研究者

发起方
Helse Fonna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunnar Helge Sjøen

Consultant in Anesthesiology

Helse Fonna

研究点 (1)

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