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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000958-56 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Propofol | Active Comparator | High Propofol induction dose |
|
| Low Propofol | Active Comparator | Low Propofol induction dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 2,4 mg/kg |
|
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar H 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 |
|---|---|---|---|
| 29245361 | Background | Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164. | |
| 3257393 | Background |
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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 |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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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 03Prop). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.
| Propofol |
| Drug |
1,4 mg/kg |
|
|
| 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 |
| Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. doi: 10.1093/bja/60.1.3. |
| 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. |
| 27199311 | Background | de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126. |
| 37291731 | Derived | Sjoen GH, Falk RS, Hauge TH, Tonnessen TI, Langesaeter E. Hemodynamic effects of a low versus a high dose of propofol during induction of anesthesia. A randomized trial. Acta Anaesthesiol Scand. 2023 Oct;67(9):1178-1186. doi: 10.1111/aas.14293. Epub 2023 Jun 8. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |