Esmolol Versus Dexmedetomidine for Opioid-sparing in Laparoscopic Gynecological Surgery

NCT07846722 | Recruiting

• 1 other identifier: 67425/4/2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute Post-Operative; Dexmedetomidine; Analgesia; Esmolol; Nociceptive Pain; Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (2)

• Total postoperative opioid consumption

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

  First 24 hours postoperatively

• PCA utilization parameters

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

  First 24 hours postoperatively

Secondary Outcomes (12)

• Postoperative pain intensity

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

• Time to first patient-controlled analgesia (PCA) activation

  Up to 24 hours postoperatively

• Satisfaction from analgesia

  6 hours postoperatively

• Time with adequate nociception control (NOL <25)

  Intraoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

Study Arms (3)

Group A - Esmolol Hydrochloride

ACTIVE COMPARATOR

Loading dose of esmolol 0.05 mL/kg (10 mg/mL) and maintenance dose of esmolol 0.3 mL/kg/h (10 mg/mL).

Drug: Esmolol hydrochloride

Group B - Dexmedetomidine

ACTIVE COMPARATOR

Loading dose of dexmedetomidine 0.05 mL/kg (4 mcg/ml) and maintenance dose of dexmedetomidine 0.3 mL/kg/h (1.67 mcg/ml).

Drug: Dexmedetomidine

Group C - Placebo

PLACEBO COMPARATOR

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

Drug: Normal (0.9%) saline

Interventions

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.

Group A - Esmolol Hydrochloride

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.

Group B - Dexmedetomidine

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.

Group C - Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• American Society of Anesthesiologists (ASA) classification I-II
• Laparoscopic hysterectomy

You may not qualify if:

• 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
• patients with a known malignancy or undergoing surgery for oncological reasons
• known allergy to a local anesthetic
• drug or alcohol abuse
• language or communication barriers
• lack of informed consent

Sponsors & Collaborators

• Vasiliki Samartzi: lead

Study Sites (1)

"Alexandra" General Hospital

Athens, 11634, Greece

RECRUITING

Related Publications (5)

• Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.

  PMID: 28413270 BACKGROUND

• Sun Y, Yao Y, Li Y, Deng W. Dexmedetomidine for opioid-sparing postoperative analgesia: a systematic review and meta-analysis. BMC Anesthesiol. 2026 Jan 13;26(1):103. doi: 10.1186/s12871-025-03606-w.

  PMID: 41527017 BACKGROUND

• Neto EDDS, de Lara FST, Abreu SN, Sanches MC, de Freitas MCF, Oliveira ARDS, Nogueira CS, Carvalho VH. Esmolol as an Adjunct in Multimodal Anesthesia: A Systematic Review and Meta-Analysis of Its Opioid-Sparing and Analgesic Effects. Anesth Analg. 2026 May 1;142(5):882-897. doi: 10.1213/ANE.0000000000007787. Epub 2025 Oct 24.

  PMID: 41134986 BACKGROUND

• Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.

  PMID: 29028742 BACKGROUND

• Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.

  PMID: 34065937 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Nociceptive Pain

Interventions

esmolol; Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Vasiliki Samartzi

CONTACT

+30 6939001517; v.samartzi2@gmail.com

Kassiani Theodoraki, PhD, DESA

CONTACT

ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Model Details: Each participant will receive both a loading dose and a maintenance infusion according to group allocation. To ensure blinding, before the start of surgery, a member of the nursing staff not involved in patient management will prepare two identical syringes (20 mL and 60 mL) containing the study medication or placebo, without disclosing their contents to the investigators, anesthesia providers, or patients.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: September 29, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)