Clinical trial NCT03861364: Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
Official title: Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamics Instability
Anesthesia, General
Anesthesia, Intravenous
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
Lead sponsor: Helse Fonna
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, double blind.
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: The first 7.5 minutes during induction of general anesthesia
measure: Heart rate (HR)
timeFrame: The first 7.5 minutes during induction of general anesthesia
Secondary outcomes:
measure: Stroke Volume (SV)
timeFrame: The first 7.5 minutes during induction of general anesthesia
measure: Cardiac Output (CO)
timeFrame: The first 7.5 minutes during induction of general anesthesia
measure: Systemic Vascular Resistance (SVR)
timeFrame: The first 7.5 minutes during induction of general anesthesia
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Kirurgisk Klinikk-Anestesi
state: Rogaland
Study officials:
affiliation: Helse Fonna
name: Gunnar H Sjøen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.
citation: Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. doi: 10.1093/bja/60.1.3.
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.
citation: de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.