Comparative Efficacity of Ephedrine Versus Norepinephrine to Correct

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05497700
Study type	Interventional
Source	Brugmann University Hospital
Contact	Denis Schmartz, MD
Phone	+3224773996
Email	denis.schmartz@chu-brugmann.be
Status	Recruiting
Phase	Phase 3
Start date	September 15, 2022
Completion date	October 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03580590` - Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery	Early Phase 1
Completed	`NCT04573842` - Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Recruiting	`NCT06426784` - Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
Completed	`NCT04603469` - Hypotension in Children With Down Syndrome With Anesthesia Induction
Recruiting	`NCT05891951` - Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery	N/A
Completed	`NCT05842759` - Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study	N/A
Recruiting	`NCT05884918` - Intraoperative Hypotension in High-risk Patients Undergoing Surgery
Completed	`NCT05239234` - Ultrasonographic Predictors of Hypotension After Induction
Not yet recruiting	`NCT04291794` - Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion	Phase 4
Completed	`NCT04051073` - Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.	Phase 3
Completed	`NCT01669434` - Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery	Phase 4
Completed	`NCT05424510` - PoCUS Guided Fluids to Prevent Post-induction Hypotension	N/A
Recruiting	`NCT05969886` - Ventricular-Arterial Coupling: A Predictor of Post-Induction Hypotension
Not yet recruiting	`NCT05536323` - Bolus Versus Continuous Remimazolam for Anesthetic Induction	N/A
Recruiting	`NCT03237429` - The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
Withdrawn	`NCT04299776` - CirQPOD Shoulder Study	N/A
Completed	`NCT03439007` - Anesthesia-induced Hypotension and Fluid Responsiveness
Completed	`NCT03787732` - Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation	Phase 4
Not yet recruiting	`NCT05960604` - Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Completed	`NCT04658576` - Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms