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Completed

NCT Number: NCT03861364

Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.

The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients 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

Kirurgisk Klinikk-Anestesi

Haugesund, Rogaland, 5504, Norway

About this study

Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, 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.

Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 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

Propofol

Drug

2,4 mg/kg

Other names: Propolipid

Primary outcomes

  1. Systolic blood pressure (SBP)

    Time frame: The first 7.5 minutes during induction of general anesthesia

    Relative change of SBP (mmHg)

  2. Heart rate (HR)

    Time frame: The first 7.5 minutes during induction of general anesthesia

    Relative change of HR (beats)

Secondary outcomes

  1. Stroke Volume (SV)

    Time frame: The first 7.5 minutes during induction of general anesthesia

    Relative change of SV (ml/beat)

  2. Cardiac Output (CO)

    Time frame: The first 7.5 minutes during induction of general anesthesia

    Relative change of CO (litre/min)

  3. Systemic Vascular Resistance (SVR)

    Time frame: The first 7.5 minutes during induction of general anesthesia

    Relative change of SVR (dynes-sec/cm5/m2)

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 Low vs High Propofol Doses.

Acronym: PH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2019
Registry last updated
Jun 17, 2020

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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