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EsmoNOL: Esmolol for NOL-guided Anesthesia
NCT06291363Phase 4
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Mar 2025
- Countries
- 1
- Modality
- Orthosteric Ligands
- Drugs
- esmolol
- Conditions
- nociceptive pain
01
Overview
Phase 4, randomised, double-blind trial in nociceptive pain comparing Esmolol with Standard of Care (2 arms). Primary endpoint: Intra operative remifentanil administration. Started Apr 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Esmolol
Esmolol 0.5 mg/kg bolus + 20 mcg/kg/min infusion + NOL-guided Remifentanil
Standard of Care
Saline placebo + NOL-guided Remifentanil
03
Endpoints
Primary
Intra operative remifentanil administration
Secondary
The NOL Index variation before and after orotracheal intubation and first surgical incision
Mean intraoperative blood pressure
Mean intraoperative heart rate
Doses and time weighted of norepinephrine, ephedrine, glycopyrrolate and atropine
Total time with NOL value above > 25
Total time and time weighted average of hypotension and/or bradycardia
Time to first analgesic requirement in PACU
Amount of morphine equivalent consumption
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