The Impact of Esmolol Administration on Postoperative Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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esmolol group

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

Group Type ACTIVE_COMPARATOR

Esmolol Hydrochloride

Intervention Type DRUG

In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively

placebo group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively

Interventions

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Esmolol Hydrochloride

In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively

Intervention Type DRUG

normal saline

In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No