The Impact of Intraoperative Esmolol and Dexmedetomidine Administration on Opioid Consumption in Laparoscopic Gynecological Procedures: A Double-blinded Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total postoperative opioid consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •American Society of Anesthesiologists (ASA) classification I-II
- •Laparoscopic hysterectomy
排除标准
- •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
研究组 & 干预措施
Group C - Placebo
Loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h.
干预措施: Normal (0.9%) saline (Drug)
Group A - Esmolol Hydrochloride
Loading dose of esmolol 0.05 mL/kg (10 mg/mL) and maintenance dose of esmolol 0.3 mL/kg/h (10 mg/mL).
干预措施: Esmolol hydrochloride (Drug)
Group B - Dexmedetomidine
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).
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Total postoperative opioid consumption
时间窗: First 24 hours postoperatively
Total morphine consumption administered via patient-controlled analgesia (PCA), expressed in milligrams (mg).
PCA utilization parameters
时间窗: First 24 hours postoperatively
Number of PCA attempts and number of successful PCA deliveries as indicators of analgesic demand and utilization efficiency.
次要结局
- Time to first patient-controlled analgesia (PCA) activation(Up to 24 hours postoperatively)
- Postoperative pain intensity(PACU arrival and discharge (1 hour), & 6, 12, and 24 hours postoperatively)
- Satisfaction from analgesia(6 hours postoperatively)
- Time with adequate nociception control (NOL <25)(Intraoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Incidence of bradycardia and hypotension and related treatment(Intraoperatively)
- Total propofol consumption(Intraoperatively)
- Sedation level on arrival and discharge from PACU(PACU admission and discharge (1 hour))
- Length of stay in the Post-Anesthesia Care Unit (PACU)(Until PACU discharge (1 hour))
- Incidence of postoperative nausea and vomiting(Up to 24 hours postoperatively)
- Change from baseline in Quality of Recovery (QoR)-15 score after surgery(24 hours postoperatively)
- Total hospital length of stay(From surgery until hospital discharge (4 days))
研究者
Vasiliki Samartzi
Anesthesiologist, Principal Investigator
National and Kapodistrian University of Athens