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Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high.
For the past few years, some teams have proposed evaluating norepinephrine as a first-line drug in the presence of hypotension or even before hypotension occurs Thus in obstetrics, the preventive use of norepinephrine for cesareans performed under spinal anesthesia was associated with a reduction in the incidence of hypotension per operative without deleterious effect for the newborn or parturient. In the absence of any observed complications, several teams began to use noradrenaline prophylactically in other surgery. However, no study has demonstrated its benefit, particularly the term of surgical complication in abdominal surgery. The objective of this work is to assess the preventive use of norepinephrine in major abdominal surgery on the occurrence of intraoperative hypotension, postoperative organ dysfunction and postoperative medical and surgical complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure. |
|
| Test group | Experimental | Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ephedrine | Drug | The control group will be taken care of according to the protocols in force. The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the of the Clavien Dindo surgical score between both groups | The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of duration of hospital stay in days between both groups | one month | |
| Length of intensive care unit stay | 1 month | |
| length of postoperative care unit stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80480 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38684243 | Derived | Trocheris-Fumery O, Scetbon C, Flet T, Meynier J, Sellier M, Rumbach M, Badaoui R, Villeret L, Tarpin P, Abou-Arab O, Bar S, Dupont H. Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY). BMJ Open. 2024 Apr 29;14(4):e083606. doi: 10.1136/bmjopen-2023-083606. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004809 | Ephedrine |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Norepinephrine | Drug | Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives. |
|
| 1 month |
| Postoperative renal function | Postoperative renal function assessed by the KDIGO score at 48 hours KDIGO (Kidney Disease: Improving Global Outcomes) stage 1 : Serum creatinine : 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5μmol/l) increase stage 2 : Serum creatinine : 2.0-2.9 times baseline stage 3 : 3 times baseline or ≥4.0 mg/dl ( ≥353.6 μmol/l) increase stage 1 : Urine output : <0.5 ml/kg/h for 6-12 h stage 21 :Urine output : <0.5 ml/kg/h for ≥12 h stage 3 : Urine output : <0.3 ml/kg/h ≥24 h or anuria ≥12h | at 48 hours |
| number of persistent circulatory shock | persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively | at 48 hours |
| number of persistent circulatory shock | persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively | at 7 days |
| number of persistent circulatory shock | persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively | at 1 month |
| number of patients with cardiac rhythm disorder | number of patients with cardiac rhythm disorder | at 1 month |
| number of patients with cardiac rhythm disorder | number of patients with cardiac rhythm disorder | at 48 hours |
| number of patients with cardiac rhythm disorder | number of patients with cardiac rhythm disorder | at 7 days |
| Number of patients with acute coronary syndrome | Number of patietns with acute coronary syndrome | at 48 hours |
| Number of patients with acute coronary syndrome | Number of patietns with acute coronary syndrome | at 1 month |
| Number of patients with acute coronary syndrome | Number of patietns with acute coronary syndrome | at 7 days |
| Number of patients with Postoperative respiratory complications: respiratory infection | Number of patients with Postoperative respiratory complications: respiratory infection | at 48 hours |
| Number of patients with Postoperative respiratory complications: respiratory infection | Number of patients with Postoperative respiratory complications: respiratory infection | at 7 days |
| Number of patients with Postoperative respiratory complications: respiratory infection | Number of patients with Postoperative respiratory complications: respiratory infection | at 1 month |
| Number of patients with Postoperative respiratory complications: atelectasis | Number of patients with Postoperative respiratory complications: atelectasis | at 1 month |
| Number of patients with Postoperative respiratory complications: atelectasis | Number of patients with Postoperative respiratory complications: atelectasis | at 48 hours |
| Number of patients with Postoperative respiratory complications: atelectasis | Number of patients with Postoperative respiratory complications: atelectasis | at 7 days |
| Number of patients with Postoperative respiratory complications: oxygen support | Number of patients with Postoperative respiratory complications: oxygen support | at 7 days |
| Number of patients with Postoperative respiratory complications: oxygen support | Number of patients with Postoperative respiratory complications: oxygen support | at 48 hours |
| Number of patients with Postoperative respiratory complications: oxygen support | Number of patients with Postoperative respiratory complications: oxygen support | at 1 month |
| Number of patients with Postoperative respiratory complications: mechanical ventilation | Number of patients with Postoperative respiratory complications: mechanical ventilation | at 7 days |
| Number of patients with Postoperative respiratory complications: mechanical ventilation | Number of patients with Postoperative respiratory complications: mechanical ventilation | at 48 hours |
| Number of patients with Postoperative respiratory complications: non-invasive ventilation | Number of patients with Postoperative respiratory complications: non-invasive ventilation | at 48 hours |
| Number of patients with Postoperative respiratory complications: non-invasive ventilation | Number of patients with Postoperative respiratory complications: non-invasive ventilation | at 7 days |
| Number of patients with Postoperative respiratory complications: non-invasive ventilation | Number of patients with Postoperative respiratory complications: non-invasive ventilation | at 1 month |
| Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | at 48 hours |
| Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | at 7 days |
| Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS) | at 1 month |
| Number of patients with Infectious complications: sepsis | Number of patients with Infectious complications: sepsis | at 48 hours |
| Number of patients with Infectious complications: sepsis | Number of patients with Infectious complications: sepsis | at 7 days |
| Number of patients with Infectious complications: sepsis | Number of patients with Infectious complications: sepsis | at 1 month |
| Number of patients with Infectious complications: sepsis shock | Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score) | at 1 month |
| Number of patients with Infectious complications: sepsis shock | Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score) | at 48 hours |
| Number of patients with Infectious complications: sepsis shock | Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score) | at 7 days |
| Number of patients with Neurological complications: altered consciousness | Number of patients with Neurological complications: altered consciousness | at 7 days |
| Number of patients with Neurological complications: altered consciousness | Number of patients with Neurological complications: altered consciousness | at 48 hours |
| Number of patients with Neurological complications: altered consciousness | Number of patients with Neurological complications: altered consciousness | at 1 month |
| Number of patients with Neurological complications: stroke | Number of patients with Neurological complications: stroke | at 1 month |
| Number of patients with Neurological complications: stroke | Number of patients with Neurological complications: stroke | at 48 hours |
| Number of patients with Neurological complications: stroke | Number of patients with Neurological complications: stroke | at 7 days |
| Number of patients haematological complications: intraoperative blood loss | Number of patients haematological complications: intraoperative blood loss | at 7 days |
| Number of patients haematological complications: intraoperative blood loss | Number of patients haematological complications: intraoperative blood loss | at 48 hours |
| Number of patients haematological complications: blood transfusion and haemostasis disorder | Number of patients haematological complications: blood transfusion and haemostasis disorder | at 48 hours |
| Number of patients haematological complications: blood transfusion and haemostasis disorder | Number of patients haematological complications: blood transfusion and haemostasis disorder | at 7 days |
| Volume of intraoperative fluid therapy | Volume of intraoperative fluid therapy | at 48 hours |
| Evaluation of the level of dependence in the activities of daily living | Evaluation of the level of dependence in the activities of daily living : IADL scale The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. | at 1 month post-discharge from the hospital |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004983 | Ethanolamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |