E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In daily clinical work we observe a hypotensive effect and a reduction in HR when induction of general anesthesia is performed using propofol and remifentanil. It is difficult to differentiate the effects of a low vs a high propofol dose during induction when administered together with a moderate remifentanil infusion. In this trial we want to examine the first question by studying the haemodynamic effects of giving a high vs a low propofol dose.
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E.1.1.1 | Medical condition in easily understood language |
Propofol is used for inducing sleep during general anesthesia. Side effects are low blood pressure and other effects on the circulatory system. We will examine the effects of a low versus high dose. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
We want to examine the haemodynamic 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 mikrogr/kg). The 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 mikrogr/kg/min (total induction dose 1.75 mikrogr/kg remifentanil) in a study by Koh et al. The study objective is to examine if there is a statistic significant difference between a high propofol induction dose vs a low dose propofol induction dose in respect to haemodynamic stability in healthy patients when giving a moderate remifentanil infusion.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The trial recruits patients from the Gynecological department, Haugesund Hospital. All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
Gynecological procedure Age 18-50 years General anesthesia planned Must have values as the following: Systolic blood pressure < 150 mmHg, HR < 100 beats/min Pregnancy test if in week of expected menstruation bleeding.
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they meet any of the following criteria:
Pre-existing hypertension Diabetes Ischemic heart disease or cerebrovascular disease Heart valve disease Verified cardiac arrhythmia other than extrasystoles Verfied anaemia with hemoglobin level below 9.0 gr/dl. Kidney or hepatic disease Hypersensitivity for propofol, soya, eggs or peanuts Pregnancy Poor health state Illicit substance use BMI <20 or >35 kg/m2
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E.5 End points |
E.5.1 | Primary end point(s) |
The relative change of SBP (mmHg), HR (beats/min) and CO (litre/min) are the primary outcomes variables.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From start until 7.5 minutes. |
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E.5.2 | Secondary end point(s) |
Relative change in SV (ml/beat) and SVR (dynes-sec/cm5/m2) are the secondary outcome variables.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From start until 7.5 minutes. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The comparator is a different dose of the same IMP |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
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E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |