Kirurgisk Klinikk-Anestesi
Haugesund, Rogaland, 5504, Norway
NCT Number: NCT03861364
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.
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Notify Me18 year–50 year
Female
Interventional
Phase 4
Haugesund, Rogaland, 5504, Norway
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2,4 mg/kg
Other names: Propolipid
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of SBP (mmHg)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of HR (beats)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of SV (ml/beat)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of CO (litre/min)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of SVR (dynes-sec/cm5/m2)
Helse Fonna
Other
Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
Acronym: PH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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