Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery
- Registration Number
- NCT05335954
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- Requiring cardiac or thoracic surgery under general anaesthesia
- Requiring a blood pressure catheter prior to GA induction
- Hemodynamic instability on arrival in the operating room
- Hypotension on arrival in the operating theatre: Systolic blood pressure < 100 mmHg or Mean arterial pressure < 65 mmHg
- Hypertension on arrival at the operating theatre: Systolic blood pressure > 160 mmHg or Mean arterial pressure > 100 mmHg
- Adult under guardianship, curatorship or safeguard of justice
- Unable to give consent
- Pregnant or breastfeeding woman
- Emergency surgery (cannot be delayed by 24 hours)
- Current participation in an interventional protocol that interferes with the evaluation criteria of the study
- Not affiliated to or not benefiting from a social security scheme
- Lack of informed and written consent from the patient
- Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
- Patient with severe aortic insufficiency
- Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Noradrenaline noradrenaline 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
- Primary Outcome Measures
Name Time Method Intubation-related hypotension Within 20 minutes of the start of general anesthesia (induction) 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
- Secondary Outcome Measures
Name Time Method Occurrence of complications Within 20 minutes of the start of the intubation 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 breakageECC Cardiac Output Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated Cardiac Output frequency in bpm (beat per minute)
Duration of episodes of hypotension Within 20 minutes of the start of the intubation Cumulative duration of episodes of hypotension \< 55mmHg
ECC Mean Arterial Pressure Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg
Total dose of vasopressor Within 20 minutes of the start of the intubation Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine)
ECC Arterial Line Temperature Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius
ECC duration Within 20 minutes of the start of the intubation Extra Corporeal Circulation duration in minutes
Hypotension event Within 20 minutes of the start of the intubation At least one Mean Arterial Pressure measurement \< 65 mmHg
Hypertension event Within 20 minutes of the start of the intubation At least one Systolic Blood Pressure measurement \> 160 mmHg or Mean Arterial Pressure \> 100mmHg
ECC SaO2 Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated SaO2 (Arterial Saturation in O2) in percentage
ECC SvO2 Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated SvO2 (Venous Saturation in O2) in percentage
ECC PaCO2 Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated PaCO2 (Arterial Pressure in CO2) in kPa
ECC Arterial Line Pressure Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated Arterial Line Pressure in mmHg
ECC VO2 Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated VO2 (Volume O2) in Liter per Minute
ECC PaO2 Within 20 minutes of the start of the intubation Extra Corporeal Circulation generated PaO2 (Arterial Pressure in O2) in kPa
Delirium score After extubation within 48 hours postoperatively 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)
Postoperative invasive ventilation duration Until 28 days after surgery Duration of postoperative invasive ventilation in hours: this duration is defined by the duration of mechanical ventilation between arrival in intensive care and extubation
Duration of Noradrenaline and Dobutamine treatments Within 28 days after surgery Duration of treatment with Noradrenaline (in hours) and Dobutamine (in hours)
PaO2/FiO2 In the 5 post-operative days Lowest value of PaO2/FiO2 (Arterial Pressure of O2 / Fraction inspired in Oxygen) measured
Dialysis Within 28 days after surgery Use of dialysis in intensive care (Yes/No)
Hemolysis index In the 5 post-operative days Maximum hemolysis index (0 to 10000, with higher scores being more pejorative)
Acute renal failure In the 5 post-operative days 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.
CVA In the 5 post-operative days Occurrence of a CVA (cerebrovascular accident)
Mortality Until 28 days after surgery Death of the patient
Stay in intensive care duration Until 28 days after surgery 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).
Hospitalization duration Until 28 days after surgery Length of hospitalization in days
Trial Locations
- Locations (1)
Chu de Nantes
🇫🇷Nantes, France
Chu de Nantes🇫🇷Nantes, France