General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Duration of Hospital Stay.
研究概览
简要总结
The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 60 years of age.
- •Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication.
- •At least one ovary planned to be preserved at the hysterectomy.
- •Can understand and communicate in Swedish
- •Accept participation after written and verbal information and after signed informed consent.
- •Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone.
排除标准
- •Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs
- •ASA classification ≥ Class 3
- •Postmenopausal women without HRT (hormone replacement therapy).
- •Suspected gynecological malignancy
- •Previously undergone bilateral oophorectomy
- •Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated.
- •Mentally or severly psychic disabled
研究组 & 干预措施
A
Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
干预措施: Bupivacain (Drug)
A
Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
干预措施: Morphine (Drug)
A
Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
干预措施: Propofol (Drug)
B
General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
干预措施: Propofol (Drug)
B
General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
干预措施: Fentanyl (Drug)
B
General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
干预措施: Rocuronbromid (Drug)
B
General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
干预措施: Morphine (Drug)
结局指标
主要结局
Duration of Hospital Stay.
时间窗: Within 6 months after surgery
Duration of hospital stay defined as time from start anesthesia to leaving the hospital
次要结局
- The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.(Within 6 months after the surgery)
- Health-related Economy.(Within 6 months after the surgery)
- Quality of Life and QALYs (Quality Adjusted Life Years).(Within 6 months after the surgery)
- Occurrence and Degree of Postoperative Symptoms.(Within 6 months after the surgery)
- Postoperative Consumption of Analgesics and Antiemetics.(Within 6 months after surgery)
- Complications and Complication Rates.(Within 6 months after the surgery)
- Sick Leave.(Within 6 months after the surgery)
研究者
Preben Kjolhede
Associate professor
University Hospital, Linkoeping