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

C

CHU Brugmann University Hospital

Status and phase

Enrolling
Phase 3

Conditions

Hypotension on Induction

Treatments

Drug: Norepinephrine
Drug: Ephedrine

Study type

Interventional

Funder types

Other

Identifiers

NCT05497700
VASO_IRC

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Ephedrine group
Active Comparator group
Description:
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.
Treatment:
Drug: Ephedrine
Norepinephrine group
Experimental group
Description:
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.
Treatment:
Drug: Norepinephrine

Trial contacts and locations

1

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Central trial contact

Denis Schmartz, MD; Zakaria Cheffi, MD

Data sourced from clinicaltrials.gov

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