Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.
- Conditions
- Anesthesia, GeneralAnesthesia, IntravenousHemodynamic Instability
- Interventions
- Registration Number
- NCT03864094
- Lead Sponsor
- Helse Fonna
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 128
- Healthy women
- Age 18-50 years
- Gynecological procedures
- General anesthesia
- Pre-existing hypertension
- Diabetes for several years
- Ischemic heart disease
- Cerebrovascular disease
- Heart valve disease
- Verified cardiac arrhythmia
- Anaemia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ephedrine Propofol Remifentanil Ephedrine Prophylactic Ephedrine Ephedrine Propofol Remifentanil Propofol Prophylactic Ephedrine Ephedrine Propofol Remifentanil Remifentanil Prophylactic Ephedrine Phenylephrine Propofol Remifentanil Phenylephrine Prophylactic Phenylephrine Phenylephrine Propofol Remifentanil Propofol Prophylactic Phenylephrine Phenylephrine Propofol Remifentanil Remifentanil Prophylactic Phenylephrine Norepinephrine Propofol Remifentanil Norepinephrine Prophylactic Norepinephrine Norepinephrine Propofol Remifentanil Propofol Prophylactic Norepinephrine Norepinephrine Propofol Remifentanil Remifentanil Prophylactic Norepinephrine Sodium chloride Propofol Remifentanil Sodium chloride NaCl Placebo Sodium chloride Propofol Remifentanil Remifentanil NaCl Placebo Sodium chloride Propofol Remifentanil Propofol NaCl Placebo
- Primary Outcome Measures
Name Time Method Heart Rate (HR) First 7,5 minutes from start of induction Change in HR during induction as measured by the LiDCOplus monitoring system
Systolic Blood Pressure (SBP) First 7,5 minutes from start of induction Change in SBP during induction as measured by the LiDCOplus monitoring system
- Secondary Outcome Measures
Name Time Method Stroke Volume (SV) First 7,5 minutes from start of induction Change in SV during induction as measured by the LiDCOplus monitoring system
Cardiac Output (CO) First 7,5 minutes from a start of induction Change in CO during induction as measured by the LiDCOplus monitoring system
Systemic Vascular Resistance (SVR) First 7,5 minutes from start of induction Change in SVR during induction as measured by the LiDCOplus monitoring system
Trial Locations
- Locations (1)
Helse Fonna, Haugesund Sykehus
🇳🇴Haugesund, Norway