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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000961-19 | EudraCT Number |
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In this trial the investigators want to examine if there is any difference in hemodynamic stability during induction when comparing two low and a medium remifentanil dose and keeping propofol induction dose at about 2.0 mg/kg.
Typically, one or more adjuvant medications is administered during induction of general anesthesia. When anesthetic drugs are combined, 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.
Remifentanil is infused at 0.05-0.3 microg/kg/min during induction of anesthesia. Some use a loading dose of 0.5-1.0 microg/kg before starting the continuous infusion. The onset of action of remifentanil is within one to two minutes and it reaches rapidly a steady state effect site concentration after a bolus dose.
Kazmaier (2000) showed that a high-dose remifentanil anesthesia (2 microg/kg/min) reduced cardiac index (-25%), stroke volume (-14%) and mean arterial blood pressure (-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. Fairfield et al have earlier (1991) showed that propofol 2.5 mg/kg induction without opioid reduces cardiac output (-15%) stroke volume (-5 %), mean arterial pressure (-33%) and systemic vascular resistance (-11%) and a slight reduction i heart rate. Guarracino (2003) suggests the reduction in cardiac index during induction with propofol/remifentanil with a low propofol target (1.2 microg/ml) may be due to decreased heart rate. Zaballos (2009) have shown that remifentanil depresses sinus node and atrioventricular (AV) -nodal function in comparison with propofol alone in a closed chest porcine model. Hayashi (2016) states that even in a low remifentanil effect site concentration (3.5 nanog/ml) it may reduce heart rate significantly when combined with propofol bolus 30-50 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil R2 | Active Comparator | Low dose Remifentanil induction dose (R2) |
|
| Remifentanil R4 | Active Comparator | Medium dose Remifentanil induction dose (R4) |
|
| Remifentanil R8 | Active Comparator | Medium dose Remifentanil induction dose (R8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil R2 | Drug | 0,7 microg/kg |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (SBP) | Change in systolic blood pressure during induction | First 7,5 minutes from start of induction |
| Heart Rate (HR) | Change in heart rate during induction | First 7,5 minutes from start of induction |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume (SV) | Change in stroke volume during induction | First 7,5 minutes from start of induction |
| Cardiac Output (CO) | Change in cardiac output during induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Sjøen, MD | Helse Fonna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirurgisk Klinikk Anestesi | Haugesund | Rogaland | 5504 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10844832 | Background | Kazmaier S, Hanekop GG, Buhre W, Weyland A, Busch T, Radke OC, Zoelffel R, Sonntag H. Myocardial consequences of remifentanil in patients with coronary artery disease. Br J Anaesth. 2000 May;84(5):578-83. doi: 10.1093/bja/84.5.578. | |
| 1751277 | Background | Fairfield JE, Dritsas A, Beale RJ. Haemodynamic effects of propofol: induction with 2.5 mg kg-1. Br J Anaesth. 1991 Nov;67(5):618-20. doi: 10.1093/bja/67.5.618. |
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LiDCO-csv raw data and processed data will be made public at the publishers site, and the supporting information by request to the Principal Investigator. Statistical Data Plan is included in Study Protocol.
The data will be stored for 15 years after end of study, and may be shared during this time frame.
The data may be shared by contacting the Principal Investigator.
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized, controlled, double blind.
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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 03Remi). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.
| Remifentanil R4 | Drug | 1,1 microg/kg |
|
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| Remifentanil R8 | Drug | 1,7 microg/kg |
|
|
| First 7,5 minutes from a start of induction |
| Systemic Vascular Resistance (SVR) | Change in systemic vascular resistance during induction | First 7,5 minutes from start of induction |
| 12790210 | Background | Guarracino F, Penzo D, De Cosmo D, Vardanega A, De Stefani R. Pharmacokinetic-based total intravenous anaesthesia using remifentanil and propofol for surgical myocardial revascularization. Eur J Anaesthesiol. 2003 May;20(5):385-90. doi: 10.1017/s0265021503000589. |
| 19457895 | Background | Zaballos M, Jimeno C, Almendral J, Atienza F, Patino D, Valdes E, Navia J, Anadon MJ. Cardiac electrophysiological effects of remifentanil: study in a closed-chest porcine model. Br J Anaesth. 2009 Aug;103(2):191-8. doi: 10.1093/bja/aep131. Epub 2009 May 20. |
| 26462495 | Background | Hayashi K, Tanaka A. Effect-site concentrations of remifentanil causing bradycardia in hypnotic and non-hypnotic patients. J Clin Monit Comput. 2016 Dec;30(6):919-924. doi: 10.1007/s10877-015-9794-4. Epub 2015 Oct 13. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |