Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.

Study Overview
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Brief Summary
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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
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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).

Official Title
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Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.

Conditions
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Hemodynamics Instability, Anesthesia, General, Anesthesia, Intravenous

Intervention / Treatment
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* Drug: Propofol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, double blind.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Propofol<br>High Propofol induction dose | Drug: Propofol<br>* 2,4 mg/kg<br>* Other names: Propolipid;|
| Active Comparator: Low Propofol<br>Low Propofol induction dose | Drug: Propofol<br>* 1,4 mg/kg<br>* Other names: Propolipid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) | Relative change of SBP (mmHg) | The first 7.5 minutes during induction of general anesthesia | 
| Heart rate (HR) | Relative change of HR (beats) | The first 7.5 minutes during induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Volume (SV) | Relative change of SV (ml/beat) | The first 7.5 minutes during induction of general anesthesia | 
| Cardiac Output (CO) | Relative change of CO (litre/min) | The first 7.5 minutes during induction of general anesthesia | 
| Systemic Vascular Resistance (SVR) | Relative change of SVR (dynes-sec/cm5/m2) | The first 7.5 minutes during induction of general anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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