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

NCT05335954 | Completed Phase 3

• 1 other identifier: RC21_0144
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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

Keywords

general anesthesia; intubation; cardiac surgery; hypotension; noradrenaline

Outcome Measures

Primary Outcomes (1)

• 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

  Within 20 minutes of the start of general anesthesia (induction)

Secondary Outcomes (26)

• Occurrence of complications

  Within 20 minutes of the start of the intubation

• Total dose of vasopressor

  Within 20 minutes of the start of the intubation

• Duration of episodes of hypotension

  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

Study Arms (2)

Noradrenaline

EXPERIMENTAL

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

Drug: noradrenaline

Standard care

NO INTERVENTION

standard care

Interventions

noradrenaline DRUG

noradrenaline

Noradrenaline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, France

Location

Related Publications (1)

• Gaillard C, Breul L, Foucher A, Rigal JC, David CH, Souab F, Canevet M, Ryan M, Bailly A, Morin H, Cadiet J, Geay C, Rozec B, Vourc'h M. Prophylactic norepinephrine infusion to reduce severe hypotension during induction of anaesthesia in patients undergoing cardiac surgery: a randomised controlled single-centre clinical trial. Br J Anaesth. 2025 Dec 10:S0007-0912(25)00795-0. doi: 10.1016/j.bja.2025.10.055. Online ahead of print.

  PMID: 41381314 DERIVED

MeSH Terms

Conditions

Heart Diseases; Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mickael VOURC'H, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient under anesthesia will not be aware of randomisation arm. the team collecting primary endpoint (hypotension under 55 mg during the 20 minutes after the start of anesthesia) will not be aware of patient assignation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: April 20, 2022
• Study Start: April 27, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)