An interventional study of Esmolol hydrochloride and Dexmedetomidine in Pain, Acute Post-Operative, Dexmedetomidine and Analgesia, sponsored by Vasiliki Samartzi. Recruiting at 1 site in Greece. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Vasiliki Samartzi · Not applicable, Interventional, and Treatment
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.
Postoperative pain remains one of the most common problems in modern anesthesiological practice, even in minimally invasive surgical techniques, such as laparoscopic gynecological procedures. Despite the use of various analgesic regimens, the need for opioids remains significant, resulting in adverse effects such as nausea, vomiting, sedation, and delayed recovery. In recent years, the focus has shifted toward opioid-sparing strategies through the use of adjunctive medications during anesthesia. Among these, esmolol and dexmedetomidine are drugs that have been studied as adjuncts for reducing intraoperative and postoperative opioid requirements.
Although the literature supports the opioid-sparing effects of both agents, data directly comparing esmolol and dexmedetomidine in the context of standardized total intravenous anesthesia (TIVA) and postoperative analgesia via PCA in laparoscopic gynecological surgeries remain limited. Furthermore, it is unclear whether esmolol can offer a benefit similar to that of dexmedetomidine, with a potentially more favorable recovery profile. Therefore, this randomized, double-blind, placebo-controlled study with three parallel groups was designed to compare the effects of intraoperative esmolol and dexmedetomidine infusions versus placebo on opioid consumption and quality of recovery.
Exclusion Criteria:
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
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
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
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.
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.
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.
Total postoperative opioid consumption
Total morphine consumption administered via patient-controlled analgesia (PCA), expressed in milligrams (mg).
Time frame: 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.
Time frame: First 24 hours postoperatively
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
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
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
Time with adequate nociception control (NOL <25)
Total duration during surgery in which the Nociception Level (NOL) index remains below 25.
Time frame: Intraoperatively
Intraoperative fentanyl consumption
Dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time frame: Intraoperatively
Incidence of bradycardia and hypotension and related treatment
Incidence of intraoperative bradycardia and/or hypotension, as well as total doses of vasoactive agents used for their management.
Time frame: Intraoperatively
Total propofol consumption
Total dose of propofol administered intraoperatively, expressed in mg/kg.
Time frame: Intraoperatively
Sedation level on arrival and discharge from PACU
Sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
Time frame: PACU admission and discharge (1 hour)
Length of stay in the Post-Anesthesia Care Unit (PACU)
Time spent in the PACU, with discharge criteria defined as White-Song score ≥12 and NRS \<4. Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable". The White-Song score assesses 7 clinical parameters, each scored from 0 to 2, for a maximum total of 14 points: Consciousness, Physical Activity, Hemodynamic Stability, Respiratory Stability, Oxygen Saturation, Postoperative Pain, Postoperative Nausea and Vomiting (PONV).
Time frame: Until PACU discharge (1 hour)
Incidence of postoperative nausea and vomiting
Occurrence of nausea and/or vomiting during the postoperative period.
Time frame: Up to 24 hours postoperatively
Change from baseline in Quality of Recovery (QoR)-15 score after surgery
The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient
Time frame: 24 hours postoperatively
Total hospital length of stay
Total duration of hospitalization from surgery to discharge, expressed in days.
Time frame: From surgery until hospital discharge (4 days)
Plan to share: No
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