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Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.
The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.
The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noradrenaline | Experimental | Noradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation |
|
| Standard care | No Intervention | standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noradrenaline | Drug | noradrenaline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation-related hypotension | Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3 | Within 20 minutes of the start of general anesthesia (induction) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of complications | Occurrence (yes/no) of complications related to the intubation: Desaturation < 80%, Severe hypotension (defined as hypotension with systolic blood pressure < 80mmHg), Cardiac arrest, Death during intubation, Difficult intubation (more than two laryngoscopies and/or the use of an alternative technique after optimization of head position, with or without external laryngeal manipulation), Heart rhythm disorder (ventricular extrasystole, ventricular fibrillation, ventricular tachycardia) Esophageal intubation, Regurgitation/inhalation, Tooth breakage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mickael VOURC'H, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Nantes | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41381314 | Derived | Gaillard C, Breul L, Foucher A, Rigal JC, David CH, Souab F, Canevet M, Ryan M, Bailly A, Morin H, Cadiet J, Geay C, Rozec B, Vourc'h M. Prophylactic norepinephrine infusion to reduce severe hypotension during induction of anaesthesia in patients undergoing cardiac surgery: a randomised controlled single-centre clinical trial. Br J Anaesth. 2026 Mar;136(3):856-864. doi: 10.1016/j.bja.2025.10.055. Epub 2025 Dec 11. |
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Patient under anesthesia will not be aware of randomisation arm. the team collecting primary endpoint (hypotension under 55 mg during the 20 minutes after the start of anesthesia) will not be aware of patient assignation.
| Within 20 minutes of the start of the intubation |
| Total dose of vasopressor | Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine) | Within 20 minutes of the start of the intubation |
| Duration of episodes of hypotension | Cumulative duration of episodes of hypotension < 55mmHg | Within 20 minutes of the start of the intubation |
| Hypotension event | At least one Mean Arterial Pressure measurement < 65 mmHg | Within 20 minutes of the start of the intubation |
| Hypertension event | At least one Systolic Blood Pressure measurement > 160 mmHg or Mean Arterial Pressure > 100mmHg | Within 20 minutes of the start of the intubation |
| ECC Cardiac Output | Extra Corporeal Circulation generated Cardiac Output frequency in bpm (beat per minute) | Within 20 minutes of the start of the intubation |
| ECC Arterial Line Pressure | Extra Corporeal Circulation generated Arterial Line Pressure in mmHg | Within 20 minutes of the start of the intubation |
| ECC Arterial Line Temperature | Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius | Within 20 minutes of the start of the intubation |
| ECC Mean Arterial Pressure | Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg | Within 20 minutes of the start of the intubation |
| ECC VO2 | Extra Corporeal Circulation generated VO2 (Volume O2) in Liter per Minute | Within 20 minutes of the start of the intubation |
| ECC duration | Extra Corporeal Circulation duration in minutes | Within 20 minutes of the start of the intubation |
| ECC SaO2 | Extra Corporeal Circulation generated SaO2 (Arterial Saturation in O2) in percentage | Within 20 minutes of the start of the intubation |
| ECC SvO2 | Extra Corporeal Circulation generated SvO2 (Venous Saturation in O2) in percentage | Within 20 minutes of the start of the intubation |
| ECC PaO2 | Extra Corporeal Circulation generated PaO2 (Arterial Pressure in O2) in kPa | Within 20 minutes of the start of the intubation |
| ECC PaCO2 | Extra Corporeal Circulation generated PaCO2 (Arterial Pressure in CO2) in kPa | Within 20 minutes of the start of the intubation |
| Delirium score | At least episode with ICDSC (Intensive Care Delirium Screening Checklist) score of 4 or more (0 to 8, binary interpretation with scores from 0 to 4 excluding the presence of delirium and scores greater than or equal to 4 indicating the presence of delirium, the highest scores are not related with greater intensity of delirium) | After extubation within 48 hours postoperatively |
| Duration of Noradrenaline and Dobutamine treatments | Duration of treatment with Noradrenaline (in hours) and Dobutamine (in hours) | Within 28 days after surgery |
| PaO2/FiO2 | Lowest value of PaO2/FiO2 (Arterial Pressure of O2 / Fraction inspired in Oxygen) measured | In the 5 post-operative days |
| Dialysis | Use of dialysis in intensive care (Yes/No) | Within 28 days after surgery |
| Hemolysis index | Maximum hemolysis index (0 to 10000, with higher scores being more pejorative) | In the 5 post-operative days |
| Acute renal failure | Occurrence of acute renal failure. This criterion will be assessed using the KDIGO (Kidney Disease: Improving Global Outcomes) scale (stage 1 to 3 with higher stages being more pejorative). Any renal attack defined as at least stage I according to this classification (1.5 to 1.9 times the base rate) will be considered as acute renal failure. The "urinary output assessment" component of the KDIGO scale will not be used because of the frequency of use of diuretics in cardiac surgery. | In the 5 post-operative days |
| CVA | Occurrence of a CVA (cerebrovascular accident) | In the 5 post-operative days |
| Postoperative invasive ventilation duration | Duration of postoperative invasive ventilation in hours: this duration is defined by the duration of mechanical ventilation between arrival in intensive care and extubation | Until 28 days after surgery |
| Stay in intensive care duration | Length of stay in intensive care in days: this duration is evaluated between the day of arrival in intensive care and the date on which the patient is considered to have left intensive care (no longer subject to monitoring in intensive care). | Until 28 days after surgery |
| Hospitalization duration | Length of hospitalization in days | Until 28 days after surgery |
| Mortality | Death of the patient | Until 28 days after surgery |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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