Anesthesia, General, Anesthesia, Intravenous, Hemodynamic Instability
Conditions
Keywords
Cardiac Output (CO), Systolic Blood Pressure (SBP), Systemic Vascular Resistance (SVR), Heart Rate (HR), Stroke Volume (SV), Lithium Dilutional Cardiac Output (LiDCO), Minimal Invasive Hemodynamic Monitor, Propofol, Remifentanil, Ephedrine, Phenylephrine, Norepinephrine
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.
Interventions
DRUGEphedrine
0,1 mg/kg
DRUGPhenylephrine
1 microg/kg
DRUGNorepinephrine
0,1 microg/kg
DRUGSodium chloride
0,1 ml/kg
DRUGPropofol
2 mg/kg
DRUGRemifentanil
1,7 microg/kg
Sponsors
Helse Fonna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized, controlled, double-blind.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy women * Age 18-50 years * Gynecological procedures * General anesthesia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | First 7,5 minutes from start of induction | Change in SBP during induction as measured by the LiDCOplus monitoring system |
| Heart Rate (HR) | First 7,5 minutes from start of induction | Change in HR during induction as measured by the LiDCOplus monitoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed