Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.
NCT ID: NCT03864094
Last Updated: 2024-10-04
Study Results
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Basic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2022-03-15
2023-12-14
Brief Summary
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Detailed Description
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Earlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-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.
Several procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.
The hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 microg/kg.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Ephedrine Propofol Remifentanil
Prophylactic Ephedrine
Ephedrine
0,1 mg/kg
Propofol
2 mg/kg
Remifentanil
1,7 microg/kg
Phenylephrine Propofol Remifentanil
Prophylactic Phenylephrine
Phenylephrine
1 microg/kg
Propofol
2 mg/kg
Remifentanil
1,7 microg/kg
Norepinephrine Propofol Remifentanil
Prophylactic Norepinephrine
Norepinephrine
0,1 microg/kg
Propofol
2 mg/kg
Remifentanil
1,7 microg/kg
Sodium chloride Propofol Remifentanil
NaCl Placebo
Sodium chloride
0,1 ml/kg
Propofol
2 mg/kg
Remifentanil
1,7 microg/kg
Interventions
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Ephedrine
0,1 mg/kg
Phenylephrine
1 microg/kg
Norepinephrine
0,1 microg/kg
Sodium chloride
0,1 ml/kg
Propofol
2 mg/kg
Remifentanil
1,7 microg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-50 years
* Gynecological procedures
* General anesthesia
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Helse Fonna
OTHER
Responsible Party
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Gunnar Helge Sjøen
Consultant in Anesthesiology
Principal Investigators
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Gunnar Sjøen, MD
Role: PRINCIPAL_INVESTIGATOR
Helse Fonna
Locations
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Helse Fonna, Haugesund Sykehus
Haugesund, , Norway
Countries
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References
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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.
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.
Turner RJ, Gatt SP, Kam PC, Ramzan I, Daley M. Administration of a crystalloid fluid preload does not prevent the decrease in arterial blood pressure after induction of anaesthesia with propofol and fentanyl. Br J Anaesth. 1998 Jun;80(6):737-41. doi: 10.1093/bja/80.6.737.
Al-Ghamdi A. Hydroxyethylstarch 6% preload does not prevent the hypotension following induction with propofol and fentanyl. Middle East J Anaesthesiol. 2004 Jun;17(5):959-68.
El-Tahan MR. Preoperative ephedrine counters hypotension with propofol anesthesia during valve surgery: a dose dependent study. Ann Card Anaesth. 2011 Jan-Apr;14(1):30-40. doi: 10.4103/0971-9784.74397.
Masjedi M, Zand F, Kazemi AP, Hoseinipour A. Prophylactic effect of ephedrine to reduce hemodynamic changes associated with anesthesia induction with propofol and remifentanil. J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):217-21. doi: 10.4103/0970-9185.130024.
Sjoen GH, Hauge TH, Falk RS, Tonnessen TI, Langesaeter E. Haemodynamic Changes After Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine Versus Placebo During Induction of General Anaesthesia: A Randomised Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70138. doi: 10.1111/aas.70138.
Other Identifiers
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2019-000965-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2019/374
Identifier Type: -
Identifier Source: org_study_id
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