Pain, Acute Post-OperativeNCT07846722
Esmolol Versus Dexmedetomidine for Opioid-sparing in Laparoscopic Gynecological Surgery
A study testing Esmolol hydrochloride, Dexmedetomidine and Normal (0.9%) saline in people with Pain, Acute Post-Operative and Dexmedetomidine, run by Vasiliki Samartzi at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Pain, Acute Post-Operative, Dexmedetomidine, Analgesia
- What is being tested?
- Esmolol hydrochloride, Dexmedetomidine and Normal (0.9%) saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jul 2026to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- Laparoscopic hysterectomy
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kassiani Theodoraki, PhD, DESA contact
Greece1 site, 1 recruiting
- Recruiting
"Alexandra" General Hospital
Athens, 11634
Vasiliki Samartzi, 6939001517, v.samartzi2@gmail.com
About this study
Official title: The Impact of Intraoperative Esmolol and Dexmedetomidine Administration on Opioid Consumption in Laparoscopic Gynecological Procedures: A Double-blinded Randomized Study
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.
Read the detailed description
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.
- Conditions
- Pain, Acute Post-Operative, Dexmedetomidine, Analgesia, Esmolol, Nociceptive Pain, Laparoscopic Hysterectomy
- Being tested
- Esmolol hydrochloride, Dexmedetomidine, Normal (0.9%) saline
- Medical subject headings
- Pain, Postoperative, Agnosia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol hydrochlorideDrug
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.
DexmedetomidineDrug
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%) salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Drug: Normal (0.9%) saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption
Total morphine consumption administered via patient-controlled analgesia (PCA), expressed in milligrams (mg).
Measured: 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.
Measured: First 24 hours postoperatively
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 6 hours postoperatively
Time with adequate nociception control (NOL <25)
Total duration during surgery in which the Nociception Level (NOL) index remains below 25.
Measured: Intraoperatively
Intraoperative fentanyl consumption
Dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Measured: 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.
Measured: Intraoperatively
Total propofol consumption
Total dose of propofol administered intraoperatively, expressed in mg/kg.
Measured: 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
Measured: 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).
Measured: Until PACU discharge (1 hour)
Incidence of postoperative nausea and vomiting
Occurrence of nausea and/or vomiting during the postoperative period.
Measured: 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
Measured: 24 hours postoperatively
Total hospital length of stay
Total duration of hospitalization from surgery to discharge, expressed in days.
Measured: From surgery until hospital discharge (4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, Acute Post-OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vasiliki Samartzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vasiliki Samartzi, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846722
- Sponsor's protocol ID
- 67425/4/2026
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28413270Sun 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.
PubMed 41527017Neto 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.
PubMed 41134986Gelineau 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.
PubMed 29028742Salome 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.
PubMed 34065937