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

Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03861364
Acronym
PH
Enrollment
68
Registered
2019-03-04
Start date
2019-09-03
Completion date
2020-05-31
Last updated
2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Anesthesia, Intravenous, Hemodynamics Instability

Keywords

Cardiac Output (CO), Systolic Blood Pressure (SBP), Systemic Vascular Resistance (SVR), Heart Rate (HR), Stroke Volume (SV), Lithium Dilutional Cardiac Output (LiDCO), Minimal Invasive Hemodynamic Monitor, Propofol, Propolipid

Brief summary

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.

Detailed description

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).

Interventions

DRUGPropofol

2,4 mg/kg

Sponsors

Helse Fonna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 03Prop). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.

Intervention model description

Randomized, controlled, double blind.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure (SBP)The first 7.5 minutes during induction of general anesthesiaRelative change of SBP (mmHg)
Heart rate (HR)The first 7.5 minutes during induction of general anesthesiaRelative change of HR (beats)

Secondary

MeasureTime frameDescription
Stroke Volume (SV)The first 7.5 minutes during induction of general anesthesiaRelative change of SV (ml/beat)
Cardiac Output (CO)The first 7.5 minutes during induction of general anesthesiaRelative change of CO (litre/min)
Systemic Vascular Resistance (SVR)The first 7.5 minutes during induction of general anesthesiaRelative change of SVR (dynes-sec/cm5/m2)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026