Clinical trial NCT05335954: Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery
Official title: Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Disorder
Hypotension
Keywords: general anesthesia
intubation
cardiac surgery
hypotension
noradrenaline
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Requiring cardiac or thoracic surgery under general anaesthesia
* Requiring a blood pressure catheter prior to GA induction

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intubation-related hypotension
timeFrame: Within 20 minutes of the start of general anesthesia (induction)
Secondary outcomes:
measure: Occurrence of complications
timeFrame: Within 20 minutes of the start of the intubation
measure: Total dose of vasopressor
timeFrame: Within 20 minutes of the start of the intubation
measure: Duration of episodes of hypotension
timeFrame: Within 20 minutes of the start of the intubation
measure: Hypotension event
timeFrame: Within 20 minutes of the start of the intubation
measure: Hypertension event
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC Cardiac Output
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC Arterial Line Pressure
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC Arterial Line Temperature
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC Mean Arterial Pressure
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC VO2
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC duration
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC SaO2
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC SvO2
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC PaO2
timeFrame: Within 20 minutes of the start of the intubation
measure: ECC PaCO2
timeFrame: Within 20 minutes of the start of the intubation
measure: Delirium score
timeFrame: After extubation within 48 hours postoperatively
measure: Duration of Noradrenaline and Dobutamine treatments
timeFrame: Within 28 days after surgery
measure: PaO2/FiO2
timeFrame: In the 5 post-operative days
measure: Dialysis
timeFrame: Within 28 days after surgery
measure: Hemolysis index
timeFrame: In the 5 post-operative days
measure: Acute renal failure
timeFrame: In the 5 post-operative days
measure: CVA
timeFrame: In the 5 post-operative days
measure: Postoperative invasive ventilation duration
timeFrame: Until 28 days after surgery
measure: Stay in intensive care duration
timeFrame: Until 28 days after surgery
measure: Hospitalization duration
timeFrame: Until 28 days after surgery
measure: Mortality
timeFrame: Until 28 days after surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Mickael VOURC'H, MD
role: PRINCIPAL_INVESTIGATOR
References: