Comparative Efficacity of Ephedrine Versus Norepinephrine to Correct Anesthesia Induction Related Hypotension

NCT05497700 | Unknown Phase 3

• 1 other identifier: VASO_IRC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotension occurs frequently after anesthesia induction and is more frequent in patients with chronic renal insufficiency. This hypotension occurs most frequently during the 20 minutes after anesthesia induction. Hypotension is commonly corrected by ephedrine bolus injection. However, presynaptic noradrenaline reserve may be lower in patients with chronic renal insufficiency rendering this treatment less effective. Another drug commonly used is norepinephrine, which action is independent of presynaptic noradrenaline storage. The primary hypothesis is that in patients with chronic renal insufficiency, bolus injection of norepinephrine will be more effective then ephedrine injections to correct hypotension after anesthesia induction. 60 patients with a glomerular filtration rate less than 45 mL/min/m2 (KDIGO classification less than grade 3b) will be included in this prospective double blind trial. All patients will be anesthetized by target-controlled infusion of propofol adjusted to a patient state index (Measured by Sedline, Masimo) of 25-50. Sufentanil injection will be based on noxious stimuli according to the attending anesthesiologist's judgement. Non-invasive blood pressure will be measured at the pre-anesthesia clinic, before induction and every minute up to 20 minutes post anesthesia induction. Episodes of hypotension, defined as a mean arterial blood pressure less than 65 mm Hg, will be treated either by a bolus injection of 6 mg ephedrine or a bolus injection of 6 mcg norepinephrine, which are equipotent doses. Seringues containing either ephedrine 3 mg/mL or norepinephrine 3 mcg/mL will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number". Randomization will be done by a computer generated list in a block randomization of 5. Primary outcome is the number of boluses needed to maintain arterial blood pressure above a mean of 65 mm Hg.

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

• Number of boluses

  Primary outcome is the number of boluses of either ephedrine or norepinephrine needed to keep mean arterial blood pressure above 65 mm Hg

  20 minutes after anesthesia induction

Study Arms (2)

Ephedrine group

ACTIVE COMPARATOR

In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mg ephedrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.

Drug: Ephedrine

Norepinephrine group

EXPERIMENTAL

In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mcg norepinephrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.

Drug: Norepinephrine

Interventions

Ephedrine DRUG

Bolus injection of 6 mg ephedrine to keep mean arterial blood pressure above 65 mm Hg

Ephedrine group

Norepinephrine DRUG

Bolus injection of either 6 mcg norepinephrine to keep mean arterial blood pressure above 65 mm Hg

Norepinephrine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective non-cardiac surgery
• general anesthesia
• chronic renal insufficiency defined as a glomerular filtration rate \< 45 mL/min/m2

You may not qualify if:

• cardiac insufficiency with a left ventricular ejection fraction \< 50%
• severe cardiomyopathy
• severe cardiac valvular disease
• use of enzyme converting inhibitors or sartans less than 24h before surgery
• use of alpha2 antihypertension medication
• chronic treatment by: noradrenaline or dopamine recapture inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Related Publications (17)

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MeSH Terms

Interventions

Ephedrine; Norepinephrine

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Denis Schmartz, MD

CONTACT

+3224773996; denis.schmartz@chu-brugmann.be

Zakaria Cheffi, MD

CONTACT

+3224773996; Zakaria.CHEFFI@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Drug will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, department of Anesthesiology

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 11, 2022
• Study Start: September 15, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)