The Efficacy of Combined Local and General Anesthesia or General Anesthesia Alone in External Dacryocystorhinostomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- postoperative pain assessment
研究概览
简要总结
To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure
详细描述
- calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions
- calculate total anesthetic time
- assess intraoperative changes in hemodynamics
- assess intraoperative blood loss
- evaluate surgeon and patient satisfaction
- recognize whether this was related with changes in postoperative analgesia .
- Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the Group G, Local infiltration of 10 ml normal saline at site of skin incision after marking and analgesia was provided by 40 µg/kg nalbuphine loaded in 10 ml syringe IV before skin incision and subsequent injections of 10-20 µg/kg nalbuphine as necessary. The last supplemental bolus of nalbuphine was given at least 30 min before the end of the operation In the Group L, Local infiltration of 10 ml mixture of 20 mg/ml lidocaine and 10 µg/ml epinephrine (instead of saline used in Group G) and normal saline in 10 ml syringe was given IV (instead of nalbuphine used in Group G).
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 50 years old.
- •American society of anesthesiologists (ASA) physical status I or II.
- •Elective unilateral Dacryocystorhinostomy with paranasal skin incision.
排除标准
- •Endoscopic Dacryocystorhinostomy.
- •Allergy to amide local anesthetics or opioids.
- •Drug abuse.
- •Pregnancy.
结局指标
主要结局
postoperative pain assessment
时间窗: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation
To quantify the intensity of postoperative pain, the patients were asked to use a 10-cm visual analog scale (VAS) grade from 0-cm (no pain) to 10-cm (the worst possible pain) 1, 2, 4, 6, 8, 12, and 24 h after extubation
hemodynamic assessment
时间窗: for 24 hours
Change in heart rate were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours
次要结局
- time to rescue analgesia(up to 24 hours of postoperative)
- extubation time(intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes))
- patient and surgeon satisfaction(assessed on the first postoperative day from both patients and surgeons.)
- The number of patients who required nalbuphine in the postoperative period,(up to 24 hours of postoperative)
- mean isoflurane %(intraoperative ( recorded every 5 minutes))
- intraoperative bleeding(at the end of surgery)
研究者
Heba Mohamed EL -Asser,MD
Heba Mohamed EL -Asser,MD
Zagazig University