E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elective ceasarean section |
Elektivt sectio |
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E.1.1.1 | Medical condition in easily understood language |
Elective ceasarean section |
Planlagt Kejsersnit |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036565 |
E.1.2 | Term | Pregnancy normal |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 |
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section recieving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate. |
At belyse, om der er betydende forskel efter administration af phenylephrin eller efedrin under elektivt sectio i relation til de ændringer, der ses hos den gravide i hjernens frontallap målt ved hjælp af NIRS, samt den føtale hjertefrekvens. Forudsagt patienten bliver spinalbedøvet.
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E.2.2 | Secondary objectives of the trial |
The changes in the maternal mean arterial pressure (MAP) and Cardiac output
The changes in umbilical cord pH og baseexcess by using either ephedrine or phenylephrine, estimated from a bloodsample from the umbilical cord. |
At belyse om der ændringer i middelarteriae tryk (MAP) samt Cardiac output hos moderen, samt efedrins og phenylephrins forskellige påvirkning på navlesnors pH og Baseexcess målt fra navlesnorsblodet. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy pregnant women at term
Over 18 years old
ASA 1-2
Undergoing elective caesarean section
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Rask gravid kvinde
Alder >18 år
ASA 1-2
Elektivt sectio
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E.4 | Principal exclusion criteria |
Allergic reactions to ephedrine or phenylephrine
High blood levels of bilirubin
HELPP syndrome
Preeclampsia (pregnancy-induced hypertension)
Non-singleton pregnancies.
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Forhøjet se-bilirubin, da icterus vil gøre NIRS måling pålidelig.
Allergi overfor efedrin eller metaoxedrin
HELPP syndrom
Præeklampsi
Flerfoldsgraviditet
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E.5 End points |
E.5.1 | Primary end point(s) |
Determine if there is more than 10 % difference in cerebral bloodflow between two groups in our trial. Further dertermine if there is more than 10% difference in the foetal heartrate before and after delivery when patients recive either phenylephrin or ephrininfusions. |
Måle om der mere end 10 % forskel i cerebral blodgennemstrømning samt vurdere om der er mere end 10% forskel i den føtale puls før og efter fødsel når patienterne modtager enten pheylephrin eller efedrininfusion. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The cerebral bloodflow is measures from before induction of spinal anaesthesia to end of surgery.
The featal heartrate i measured from before induction of spinal anaesthesia to 15 min after delivery. |
Begge effektmål vurderes perioperativt. Den cerebrale gennemblødning måles fra induktionen(starten af bedøvelsen) til kirurgen er færdig.
Den føtale puls måles fra starten af bedøvelsen til 15 min efter forløsning af barnet. |
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E.5.2 | Secondary end point(s) |
To determine if there is a difference in mean arterial pressure and cardiac output of more than 10% for the woman between the the two randomised groups.
The use of phenylephrin or ephrininfusions and the influenze on umbilical cord pH and Base excess, estimated from a umbilical cord blood sample. |
Vurdere om der er mere end 10% forskel i middelarterielt blodtryk samt cardiac output i de to randomiserede grupper.
Phenylephrins eller efedrins påvirkning af pH og baseexcess målt i navlestrengblod efter fødslen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The mean arterial pressure and cardiac output is measures from before induction of spinal anaesthesia to end of surgery.
pH and baseexcess is measures afetr delivery when the bloodsample is taken from the umbilical cord. |
Middelalarterieblod tryk og cardiac output målrs fra før induktionen af spinalanæstesien og afslutningen af kirurgien.
pH og baseexcess måles efter fødslen når der er taget en navlesnorsblodprøve. |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
Physiology mechanism in the brain and the body |
fysiologiske mekanismer i hjernen og kroppen |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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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The GCP-unit of Copenhagen |
GCP enheden København |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |