Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery

NCT ID: NCT05335954

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2023-12-12

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.

Conditions

Cardiac Disorder; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

noradrenaline

Intervention Type: DRUG

noradrenaline

Standard care

standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

noradrenaline

noradrenaline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickael VOURC'H, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Chu de Nantes

Nantes, , France

Countries

France

Other Identifiers

RC21_0144

Identifier Type: -

Identifier Source: org_study_id