The Impact of Esmolol Administration on Postoperative Recovery (esmolol)

Aretaieion University Hospital

Status: Enrolling

Conditions: Inguinal Hernia Repair; Esmolol; Nociceptive Pain; Pain, Acute; Pain, Postoperative; Analgesia; Pain, Chronic Post-Surgical

Treatments: Drug: Esmolol Hydrochloride; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05567822

89/24-03-2022

Details and patient eligibility

About

The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Full description

Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• American Society of Anesthesiologists (ASA) classification I-II
• elective inguinal hernia repair

Exclusion criteria

• body mass index (BMI) >35 kg/m2
• β-blocker administration preoperatively
• systematic use of analgesic agents preoperatively
• chronic pain syndromes preoperatively
• neurological or psychiatric disease on treatment
• pregnancy
• severe hepatic or renal disease
• history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
• hemodynamic instability
• drug or alcohol abuse
• language or communication barriers
• lack of informed consent
• bilateral inguinal hernia repair

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

esmolol group

Active Comparator group

Description:

loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h

Treatment:

Drug: Esmolol Hydrochloride

placebo group

Placebo Comparator group

Description:

loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h

Treatment:

Drug: normal saline