Anesthesia, General, Anesthesia, Intravenous, Hemodynamics 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, Propolipid
Brief summary
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.
Detailed description
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).
Interventions
2,4 mg/kg
Sponsors
Study design
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 03Prop). 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
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) | The first 7.5 minutes during induction of general anesthesia | Relative change of SBP (mmHg) |
| Heart rate (HR) | The first 7.5 minutes during induction of general anesthesia | Relative change of HR (beats) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Volume (SV) | The first 7.5 minutes during induction of general anesthesia | Relative change of SV (ml/beat) |
| Cardiac Output (CO) | The first 7.5 minutes during induction of general anesthesia | Relative change of CO (litre/min) |
| Systemic Vascular Resistance (SVR) | The first 7.5 minutes during induction of general anesthesia | Relative change of SVR (dynes-sec/cm5/m2) |
Countries
Norway