Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- CRP
研究概览
简要总结
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies.
This prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.
详细描述
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols.
Glucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear.
This prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management.
All patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements.
The findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •ASA physical status I-II
- •Scheduled for elective laparoscopic cholecystectomy
- •Undergoing general anesthesia
- •Ability to provide written informed consent
排除标准
- •Patients younger than 18 years or older than 65 years
- •Known allergy to dexamethasone
- •ASA physical status III or higher
- •Surgical procedures lasting longer than 120 minutes
- •Emergency surgeries
- •Pregnant or breastfeeding patients
- •Patients with coagulopathy or receiving anticoagulant therapy
- •Known allergy to local anesthetics
- •Localized infection at the injection site
- •Inflammatory bowel disease
- •Autoimmune diseses
- •Chronic pain conditions
- •Ocular herpes simplex infection
- •Cushing's disease
- •Myasthenia gravis
- •Anticipated poor compliance with the study protocol
- •Vaccination within the last 14 days
- •Use of systemic glucocorticoids or immunosuppressive drugs
- •İmpaired renal function (GFR < 30 mL/min)
- •Liver cirrhosis
- •Congestive heart failure
- •Peripheral nerve disorders
- •Elective laparoscopic cholecystectomy due to malignancy
- •Conversion to open surgery during the operation
- •Body mass index (BMI) > 30 kg/m²
研究组 & 干预措施
D1: Moderate-dose dexamethasone
干预措施: TAP Block (Procedure)
D1: Moderate-dose dexamethasone
干预措施: moderate dose Dexamethasone (Drug)
D2: High-dose dexamethasone
干预措施: TAP Block (Procedure)
D2: High-dose dexamethasone
干预措施: High dose dexamethasone (Drug)
S: Control (normal saline)
干预措施: Saline (0.9% NaCl) (Other)
S: Control (normal saline)
干预措施: TAP Block (Procedure)
结局指标
主要结局
CRP
时间窗: preoperative and up to 18 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
时间窗: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively
Quality of Recovery (QoR-15 Score)
时间窗: 18 hours after surgery
wbc
时间窗: preoperative and up to 18 hours postoperatively
次要结局
- Postoperative Pain Intensity (VAS)(30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively)
- Intraoperative Remifentanil Consumption(Intraoperative period)
- Postoperative Opioid Consumption(Up to 18 hours postoperatively)
- Rescue Analgesic Requirement(Up to 18 hours postoperatively)
- Shoulder Pain(Up to 18 hours postoperatively)
- Adverse Events(Intraoperative and up to 10 days postoperatively)