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

Helse Fonna

Status and phase: Completed; Phase 4

Conditions: Anesthesia, General; Hemodynamics Instability; Anesthesia, Intravenous

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03861364

2019/375

2019-000958-56 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

High Propofol

Active Comparator group

Description:

High Propofol induction dose

Treatment:

Drug: Propofol

Drug: Propofol

Low Propofol

Active Comparator group

Description:

Low Propofol induction dose

Treatment:

Drug: Propofol

Drug: Propofol