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
Overview
- Phase
- Phase 3
- Intervention
- noradrenaline
- Conditions
- Cardiac Disorder
- Sponsor
- Nantes University Hospital
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Intubation-related hypotension
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Arms & Interventions
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
Intervention: noradrenaline
Outcomes
Primary Outcomes
Intubation-related hypotension
Time Frame: 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 Outcomes
- Occurrence of complications(Within 20 minutes of the start of the intubation)
- ECC Cardiac Output(Within 20 minutes of the start of the intubation)
- Duration of episodes of hypotension(Within 20 minutes of the start of the intubation)
- ECC Mean Arterial Pressure(Within 20 minutes of the start of the intubation)
- Total dose of vasopressor(Within 20 minutes of the start of the intubation)
- ECC Arterial Line Temperature(Within 20 minutes of the start of the intubation)
- ECC duration(Within 20 minutes of the start of the intubation)
- Hypotension event(Within 20 minutes of the start of the intubation)
- Hypertension event(Within 20 minutes of the start of the intubation)
- ECC SaO2(Within 20 minutes of the start of the intubation)
- ECC SvO2(Within 20 minutes of the start of the intubation)
- ECC PaCO2(Within 20 minutes of the start of the intubation)
- ECC Arterial Line Pressure(Within 20 minutes of the start of the intubation)
- ECC VO2(Within 20 minutes of the start of the intubation)
- ECC PaO2(Within 20 minutes of the start of the intubation)
- Delirium score(After extubation within 48 hours postoperatively)
- Postoperative invasive ventilation duration(Until 28 days after surgery)
- Duration of Noradrenaline and Dobutamine treatments(Within 28 days after surgery)
- PaO2/FiO2(In the 5 post-operative days)
- Dialysis(Within 28 days after surgery)
- Hemolysis index(In the 5 post-operative days)
- Acute renal failure(In the 5 post-operative days)
- CVA(In the 5 post-operative days)
- Mortality(Until 28 days after surgery)
- Stay in intensive care duration(Until 28 days after surgery)
- Hospitalization duration(Until 28 days after surgery)