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Completed

NCT Number: NCT03861377

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kirurgisk Klinikk Anestesi

Haugesund, Rogaland, 5504, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remifentanil R2

Drug

0,7 microg/kg

Other names: Ultiva

Remifentanil R4

Drug

1,1 microg/kg

Other names: Ultiva

Remifentanil R8

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 systolic blood pressure during induction

  2. Heart Rate (HR)

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

    Change in heart rate during induction

Secondary outcomes

  1. Stroke Volume (SV)

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

    Change in stroke volume during induction

  2. Cardiac Output (CO)

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

    Change in cardiac output during induction

  3. Systemic Vascular Resistance (SVR)

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

    Change in systemic vascular resistance during induction

Sponsors and collaborators

Lead sponsor

Helse Fonna

Other

Registry information

Official study title

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

Acronym: RH

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2019
Registry last updated
Mar 21, 2022

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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