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Esmolol Versus Dexmedetomidine for Opioid-sparing in Laparoscopic Gynecological Surgery

ConditionsPain, Acute Post-OperativeDexmedetomidineAnalgesiaEsmololNociceptive PainLaparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-70
SponsorVasiliki Samartzi

About this trial

The aim of this study is to investigate and compare the effects of a continuous infusion of low-dose esmolol and dexmedetomidine versus placebo on intraoperative and postoperative opioid consumption and analgesic efficacy in patients undergoing laparoscopic hysterectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients

American Society of Anesthesiologists (ASA) classification I-II

Laparoscopic hysterectomy

Disqualifiers

body mass index (BMI) >35 kg/m2

β-blocker administration preoperatively

systematic use of analgesic agents preoperatively

chronic pain syndromes preoperatively

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esmolol hydrochloride

    Drug

    In the esmolol group, patients will receive a loading dose of esmolol administered over 10 minutes in 100 mL of normal saline, followed by a continuous intraoperative esmolol infusion.

  • Dexmedetomidine

    Drug

    In the dexmedetomidine group, patients will receive a loading dose of dexmedetomidine administered over 10 minutes in 100 mL of normal saline, followed by a continuous intraoperative dexmedetomidine infusion.

  • Normal (0.9%) saline

    Drug

    In the placebo group, patients will receive a loading dose of normal saline administered over 10 minutes in 100 mL of normal saline, followed by a continuous intraoperative normal saline infusion.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group A - Esmolol HydrochlorideActive comparator 1 intervention
Group B: Group B - DexmedetomidineActive comparator 1 intervention
Group C: Group C - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative opioid consumption

Total morphine consumption administered via patient-controlled analgesia (PCA), expressed in milligrams (mg).

Time frame
First 24 hours postoperatively
2

PCA utilization parameters

Number of PCA attempts and number of successful PCA deliveries as indicators of analgesic demand and utilization efficiency.

Time frame
First 24 hours postoperatively

Secondary outcomes

1

Postoperative pain intensity

Pain intensity will be assessed using the Numerical Rating Scale (NRS) at rest and during coughing ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable". Measurements will be recorded in the Post-Anesthesia Care Unit (PACU) at arrival and discharge, and at 6, 12, and 24 hours postoperatively.

Time frame
PACU arrival and discharge (1 hour), & 6, 12, and 24 hours postoperatively
2

Time to first patient-controlled analgesia (PCA) activation

Time elapsed from arrival in the PACU to the first demand for analgesia via the PCA device.

Time frame
Up to 24 hours postoperatively
3

Satisfaction from analgesia

Satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction

Time frame
6 hours postoperatively
4

Time with adequate nociception control (NOL <25)

Total duration during surgery in which the Nociception Level (NOL) index remains below 25.

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vasiliki Samartzi

Lead sponsor

National and Kapodistrian University of Athens

Sponsor institution

Source ClinicalTrials.gov
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