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| ID | Type | Description | Link |
|---|---|---|---|
| SJ-271 | Other Identifier | Sponsor´s protocol code number |
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ephedrine | Active Comparator |
| |
| Phenylephrine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ephedrine | Drug | An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frontal lobe cerebral oxygenation | Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery. | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour |
| Foetal heartrate | From before induction of spinal anaesthesia to 15 min after delivery | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure | The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery. | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour |
| Cardiac output |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Visti Foss | Naestved Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naestved Hospital | Næstved | 4700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32619039 | Derived | Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4. | |
| 24624090 | Derived | Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014. |
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| ID | Term |
|---|---|
| D004809 | Ephedrine |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Phenylephrine | Drug | An infusion of maximum 4 mg/hour for maximum 60 minutes. |
|
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The cardiac output is measures from before induction of spinal anaesthesia to end of surgery. |
| Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour |
| Umbilical cord pH and Base excess | The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth. | Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes. |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004983 | Ethanolamines |