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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
211
noradrenaline
Chu de Nantes
Nantes, France
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
Time frame: Within 20 minutes of the start of general anesthesia (induction)
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
Time frame: Within 20 minutes of the start of the intubation
Total dose of vasopressor
Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine)
Time frame: Within 20 minutes of the start of the intubation
Duration of episodes of hypotension
Cumulative duration of episodes of hypotension \< 55mmHg
Time frame: Within 20 minutes of the start of the intubation
Hypotension event
At least one Mean Arterial Pressure measurement \< 65 mmHg
Time frame: 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
Time frame: Within 20 minutes of the start of the intubation
ECC Cardiac Output
Extra Corporeal Circulation generated Cardiac Output frequency in bpm (beat per minute)
Time frame: Within 20 minutes of the start of the intubation
ECC Arterial Line Pressure
Extra Corporeal Circulation generated Arterial Line Pressure in mmHg
Time frame: Within 20 minutes of the start of the intubation
ECC Arterial Line Temperature
Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius
Time frame: Within 20 minutes of the start of the intubation
ECC Mean Arterial Pressure
Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg
Time frame: Within 20 minutes of the start of the intubation
ECC VO2
Extra Corporeal Circulation generated VO2 (Volume O2) in Liter per Minute
Time frame: Within 20 minutes of the start of the intubation
ECC duration
Extra Corporeal Circulation duration in minutes
Time frame: Within 20 minutes of the start of the intubation
ECC SaO2
Extra Corporeal Circulation generated SaO2 (Arterial Saturation in O2) in percentage
Time frame: Within 20 minutes of the start of the intubation
ECC SvO2
Extra Corporeal Circulation generated SvO2 (Venous Saturation in O2) in percentage
Time frame: Within 20 minutes of the start of the intubation
ECC PaO2
Extra Corporeal Circulation generated PaO2 (Arterial Pressure in O2) in kPa
Time frame: Within 20 minutes of the start of the intubation
ECC PaCO2
Extra Corporeal Circulation generated PaCO2 (Arterial Pressure in CO2) in kPa
Time frame: 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)
Time frame: After extubation within 48 hours postoperatively
Duration of Noradrenaline and Dobutamine treatments
Duration of treatment with Noradrenaline (in hours) and Dobutamine (in hours)
Time frame: Within 28 days after surgery
PaO2/FiO2
Lowest value of PaO2/FiO2 (Arterial Pressure of O2 / Fraction inspired in Oxygen) measured
Time frame: In the 5 post-operative days
Dialysis
Use of dialysis in intensive care (Yes/No)
Time frame: Within 28 days after surgery
Hemolysis index
Maximum hemolysis index (0 to 10000, with higher scores being more pejorative)
Time frame: 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.
Time frame: In the 5 post-operative days
CVA
Occurrence of a CVA (cerebrovascular accident)
Time frame: 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
Time frame: 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).
Time frame: Until 28 days after surgery
Hospitalization duration
Length of hospitalization in days
Time frame: Until 28 days after surgery
Mortality
Death of the patient
Time frame: Until 28 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.