Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
研究概览
简要总结
Patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or general anesthesia with endotracheal intubation. The investigators aim to evaluate the feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.
详细描述
Commonly, laparoscopic gynecological procedures are performed under general anesthesia with endotracheal intubation.
The use of regional anesthesia in laparoscopy is reserved to patients declared unfit for general anesthesia because of severe comorbidities or it is applied in combination with general anesthesia to decrease postoperative pain.
Recently, growing literature evidence supports the use of regional anesthesia in patients undergoing laparoscopy.
The combination of minimally invasive surgery with regional anesthesia could increase the advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing gynecological laparoscopic surgery;
- •expected surgical time shorter than 90 minutes;
- •informed consent to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
干预措施: Midazolam (Drug)
Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
干预措施: Sufentanil (Drug)
Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
干预措施: Propofol (Drug)
Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
干预措施: Rocuronium (Drug)
Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
干预措施: Sevoflurane (Drug)
Group B: regional anesthesia
Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
干预措施: Sufentanil (Drug)
Group B: regional anesthesia
Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
时间窗: From the surgery time, assessed up to 7 days after surgery
Evaluation of feasibility and safety of regional anesthesia for gynecological laparoscopic surgery, considering complications using Clavien-Dindo Classification (from Grade I to V)
次要结局
- Postoperative nausea or emesis.(48 hours after surgery)
- Days of hospitalization(From surgery to hospitalization discharge, assessed up to 7 days after surgery.)
- Day of mobilization.(From surgery to day of first mobilization, assessed up to 7 days after surgery.)
- Day of feeding.(From surgery to day of first feeding, assessed up to 7 days after surgery.)
- Day of canalization.(From surgery to day of first canalization, assessed up to 7 days after surgery.)
- Intraoperative pain: verbal numeric rating scale(Intraoperative: from skin incision to cutaneous suture.)
- Minimum respiratory rate(Intraoperative: from skin incision to cutaneous suture.)
- End-Tidal PCO2 before pneumoperitoneum.(Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.)
- End-Tidal PCO2 during pneumoperitoneum.(Intraoperative: pneumoperitoneum time expressed in minutes.)
- Postoperative pain: numerical rating scale(48 hours after surgery)
研究者
Mohamed Mabrouk
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna