Pain, Acute Post-Operative, Dexmedetomidine, Analgesia, Esmolol, Nociceptive Pain, Laparoscopic Hysterectomy
Conditions
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.
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.
Interventions
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.
DRUGDexmedetomidine
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.
Sponsors
Vasiliki Samartzi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* adult patients * American Society of Anesthesiologists (ASA) classification I-II * Laparoscopic hysterectomy
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption | First 24 hours postoperatively | Total morphine consumption administered via patient-controlled analgesia (PCA), expressed in milligrams (mg). |
| PCA utilization parameters | First 24 hours postoperatively | Number of PCA attempts and number of successful PCA deliveries as indicators of analgesic demand and utilization efficiency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | PACU arrival and discharge (1 hour), & 6, 12, and 24 hours postoperatively | 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 to first patient-controlled analgesia (PCA) activation | Up to 24 hours postoperatively | Time elapsed from arrival in the PACU to the first demand for analgesia via the PCA device. |
| Satisfaction from analgesia | 6 hours postoperatively | Satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction |
| Time with adequate nociception control (NOL <25) | Intraoperatively | Total duration during surgery in which the Nociception Level (NOL) index remains below 25. |
| Intraoperative fentanyl consumption | Intraoperatively | Dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value |
| Incidence of bradycardia and hypotension and related treatment | Intraoperatively | Incidence of intraoperative bradycardia and/or hypotension, as well as total doses of vasoactive agents used for their management. |
| Total propofol consumption | Intraoperatively | Total dose of propofol administered intraoperatively, expressed in mg/kg. |
| Sedation level on arrival and discharge from PACU | PACU admission and discharge (1 hour) | 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 |
| Length of stay in the Post-Anesthesia Care Unit (PACU) | Until PACU discharge (1 hour) | 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). |
| Incidence of postoperative nausea and vomiting | Up to 24 hours postoperatively | Occurrence of nausea and/or vomiting during the postoperative period. |
| Change from baseline in Quality of Recovery (QoR)-15 score after surgery | 24 hours postoperatively | 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 |
| Total hospital length of stay | From surgery until hospital discharge (4 days) | Total duration of hospitalization from surgery to discharge, expressed in days. |
Countries
Greece
Contacts
CONTACTVasiliki Samartzi
CONTACTKassiani Theodoraki, PhD, DESA
Outcome results
None listed