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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-05-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Hemodynamics Instability Anesthesia, General Anesthesia, Intravenous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, double blind.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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High Propofol

High Propofol induction dose

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

2,4 mg/kg

Low Propofol

Low Propofol induction dose

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

1,4 mg/kg

Interventions

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Propofol

2,4 mg/kg

Intervention Type DRUG

Propofol

1,4 mg/kg

Intervention Type DRUG

Other Intervention Names

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Propolipid Propolipid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No