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A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.
Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors.
Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenylephrine and norepinephrine | Active Comparator | Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension. |
|
| Norepinephrine and phenylephrine | Other | Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenylephrine | Drug | phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the tissue oxygenation | it means the tissue oxygen delivery and consumption | from the beginning of surgery to the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 2, 2018 | |
| Unrelease | Jan 29, 2019 | |
| Release | Jan 30, 2019 | |
| Reset | May 8, 2019 | |
| Release | Jun 27, 2019 | |
| Unrelease | Jul 18, 2019 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2018 | Jan 21, 2018 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 2, 2018 | Jan 29, 2019 | |||
| Jan 30, 2019 |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D014662 | Vasoconstrictor Agents |
| D009638 | Norepinephrine |
| D002395 | Catecholamines |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Norepinephrine | Drug | Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension |
|
|
| May 8, 2019 |
| Jun 27, 2019 | Jul 18, 2019 |
| D000588 |
| Amines |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |