Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses.

Hemodynamic Instability Clinical Trial

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Official title:

"Hemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Medium and Low Remifentanil Doses."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861377
• Other study ID #: 2019/376
• Secondary ID: 2019-000961-19
• Status: Completed
• Phase: Phase 4
• Start date: June 9, 2020
• Est. completion date: February 2, 2022

Study information

• Verified date: March 2022
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gynecological procedure

• Age 18-50 years

• General anesthesia planned

• Systolic blood pressure < 150 mmHg, HR < 100 beats/min

Exclusion Criteria:

• Pre-existing hypertension

• Diabetes

• Ischemic heart disease or cerebrovascular disease

• Heart valve disease

• Verified cardiac arrhythmia other than extrasystoles

• Verified anaemia with hemoglobin level below 9.0 gr/dl.

• Kidney or hepatic disease

• Hypersensitivity for propofol, soya, eggs or peanuts

• Pregnancy

• Poor health state

• Illicit substance use

• BMI <20 or >35 kg/m2

Related Conditions & MeSH terms

• Anesthesia, General
• Anesthesia, Intravenous
• Hemodynamic Instability

Intervention

Drug:
• Remifentanil R2
0,7 microg/kg
• Remifentanil R4
1,1 microg/kg
• Remifentanil R8
1,7 microg/kg

Locations

Country	Name	City	State
Norway	Kirurgisk Klinikk Anestesi	Haugesund	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Fonna

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Epub 2015 Oct 13. — View Citation

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. — View Citation

Zaballos M, Jimeno C, Almendral J, Atienza F, Patiño D, Valdes E, Navia J, Anadón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure (SBP)	Change in systolic blood pressure during induction	First 7,5 minutes from start of induction
Primary	Heart Rate (HR)	Change in heart rate during induction	First 7,5 minutes from start of induction
Secondary	Stroke Volume (SV)	Change in stroke volume during induction	First 7,5 minutes from start of induction
Secondary	Cardiac Output (CO)	Change in cardiac output during induction	First 7,5 minutes from a start of induction
Secondary	Systemic Vascular Resistance (SVR)	Change in systemic vascular resistance during induction	First 7,5 minutes from start of induction