Comparison of the Effects of Epidural Anesthesia and General Anesthesia on Postoperative Respiratory Function and Pain in Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Peak Expiratory Flow Rate (PEFR)
研究概览
简要总结
This randomized controlled study will compare epidural anesthesia with general anesthesia in women undergoing elective laparoscopic hysterectomy. A total of 70 participants will be randomly assigned to receive either epidural anesthesia or general anesthesia.
The main aim of the study is to determine whether the type of anesthesia affects respiratory function after surgery. Respiratory function will primarily be assessed using peak expiratory flow rate (PEFR) before surgery and at 2, 6, and 24 hours after surgery.
The study will also compare postoperative pain, opioid consumption, respiratory and hemodynamic parameters, recovery, mobilization, and other perioperative outcomes between the two groups.
The researchers aim to determine whether epidural anesthesia may provide an alternative anesthetic approach for selected patients undergoing laparoscopic hysterectomy while maintaining spontaneous breathing.
详细描述
This is a prospective, single-center, randomized, controlled, parallel-group study involving 70 adult women scheduled for elective laparoscopic total hysterectomy.
Participants will be randomly allocated in a 1:1 ratio to an epidural anesthesia group or a general anesthesia group. In the epidural anesthesia group, anesthesia will be provided through a lumbar epidural catheter, with spontaneous ventilation maintained. Sedation will be provided as required. In the general anesthesia group, anesthesia will be induced intravenously, followed by endotracheal intubation and controlled mechanical ventilation.
Respiratory function will be evaluated using peak expiratory flow rate (PEFR) before surgery and at 2, 6, and 24 hours after surgery. Postoperative pain scores, opioid consumption, respiratory and hemodynamic parameters, recovery characteristics, mobilization, and perioperative adverse events will also be evaluated.
Participants in the epidural anesthesia group may be converted to general anesthesia if the epidural block is inadequate, the participant cannot tolerate the procedure, or conversion is considered clinically necessary.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- Female patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) ≤30 kg/m²
- Scheduled for elective laparoscopic total hysterectomy
- Willing and able to provide informed consent
排除标准
- Contraindication to neuraxial anesthesia
- Severe cardiopulmonary disease
- BMI >30 kg/m²
- Pre-existing neurological disorder
- Inability to cooperate with the study procedures
- Refusal to participate in the study
研究组 & 干预措施
Epidural Anesthesia
Participants assigned to this arm will receive epidural anesthesia via a lumbar epidural catheter. An initial dose of 10 mL of 0.5% bupivacaine with 50 mcg fentanyl will be administered, followed by incremental doses of 2-3 mL of 0.5% bupivacaine every 5 minutes as required to achieve a T4 sensory block, up to approximately 20 mL. Spontaneous ventilation will be maintained. Dexmedetomidine will be administered at 0.2 mcg/kg/h for sedation. Conversion to general anesthesia will be performed if the epidural block is inadequate, the participant cannot tolerate the procedure, or conversion is clinically required.
干预措施: epidural anesthesia (Procedure)
General Anesthesia
Participants assigned to this arm will receive standard general anesthesia. Anesthesia will be induced with propofol 2-2.5 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium 0.6 mg/kg, followed by endotracheal intubation. Anesthesia will be maintained with sevoflurane and controlled mechanical ventilation, with end-tidal carbon dioxide maintained between 35 and 40 mmHg.
干预措施: General Anesthesia (GA) (Procedure)
结局指标
主要结局
Change in Peak Expiratory Flow Rate (PEFR)
时间窗: Preoperative baseline and 2, 6, and 24 hours after surgery
Peak expiratory flow rate (PEFR), measured in liters per minute (L/min), will be assessed before surgery and at 2, 6, and 24 hours after surgery. The change in PEFR from the preoperative baseline will be compared between the epidural anesthesia and general anesthesia groups
次要结局
未报告次要终点
研究者
Sabiha Başarı
Anaesthesiology and Intensive Care Specialist
Kutahya City Hospital
研究点 (1)
标识符
- NCT 编号
- NCT07847801
- 其他研究编号
- KSH-ARKHD-001
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
De-identified individual participant data that underlie the results reported in the published article may be shared upon reasonable request to the corresponding author.