Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

Hemodynamic Instability Clinical Trial

— VH  

Official title:

"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo."

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864094
• Other study ID #: 2019/374
• Secondary ID: 2019-000965-19
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Helse Fonna
• Contact: Haldis Økland Lier
• Phone: 004752732000
• Email: haldis.johanne.okland.lier[@]helse-fonna.no
• 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 when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.

Description:

The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy women

• Age 18-50 years

• Gynecological procedures

• General anesthesia

Exclusion Criteria:

• Pre-existing hypertension

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Anesthesia, Intravenous
• Hemodynamic Instability

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Norway	Helse Fonna, Haugesund Sykehus	Haugesund

Sponsors (1)

Lead Sponsor	Collaborator
Helse Fonna

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — 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. doi: 10.1093/bja/84.5.578. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure (SBP)	Change in SBP during induction as measured by the LiDCOplus monitoring system	First 7,5 minutes from start of induction
Primary	Heart Rate (HR)	Change in HR during induction as measured by the LiDCOplus monitoring system	First 7,5 minutes from start of induction
Secondary	Stroke Volume (SV)	Change in SV during induction as measured by the LiDCOplus monitoring system	First 7,5 minutes from start of induction
Secondary	Cardiac Output (CO)	Change in CO during induction as measured by the LiDCOplus monitoring system	First 7,5 minutes from a start of induction
Secondary	Systemic Vascular Resistance (SVR)	Change in SVR during induction as measured by the LiDCOplus monitoring system	First 7,5 minutes from start of induction