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Completed

NCT Number: NCT03864094

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helse Fonna, Haugesund Sykehus

Haugesund, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine

Drug

0,1 mg/kg

Other names: Ephedrine Sulphate Injection

Phenylephrine

Drug

1 microg/kg

Other names: Phenylephrine Hydrocloride Injection

norepinephrine

Drug

0,1 microg/kg

Other names: Noradrenalin

Sodium Chloride

Drug

0,1 ml/kg

Other names: Sodium Chloride 0,9% injection

Propofol

Drug

2 mg/kg

Other names: Propolipid

Remifentanil

Drug

1,7 microg/kg

Other names: Ultiva

Primary outcomes

  1. Systolic Blood Pressure (SBP)

    Time frame: First 7,5 minutes from start of induction

    Change in SBP during induction as measured by the LiDCOplus monitoring system

  2. Heart Rate (HR)

    Time frame: First 7,5 minutes from start of induction

    Change in HR during induction as measured by the LiDCOplus monitoring system

Secondary outcomes

  1. Stroke Volume (SV)

    Time frame: First 7,5 minutes from start of induction

    Change in SV during induction as measured by the LiDCOplus monitoring system

  2. Cardiac Output (CO)

    Time frame: First 7,5 minutes from a start of induction

    Change in CO during induction as measured by the LiDCOplus monitoring system

  3. Systemic Vascular Resistance (SVR)

    Time frame: First 7,5 minutes from start of induction

    Change in SVR during induction as measured by the LiDCOplus monitoring system

Sponsors and collaborators

Lead sponsor

Helse Fonna

Other

Registry information

Official study 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."

Acronym: VH

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2019
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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