Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Quality of surgical field.
研究概览
简要总结
Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.
详细描述
After obtaining local ethical committee approval and written informed consent from the patients, 225 adult patients, scheduled for elective middle ear surgery in Ain Shams University hospitals will be enrolled in this randomized, prospective controlled study.
After applying basic monitors (ECG, pulse oximetry, non-invasive blood pressure monitoring and capnography), all patients will be premedicated with midazolam 0.02 mg.kg -1 IV and ranitidine 50 mg IV, 15 min. prior to surgery.
All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1. Rate of infusion will be adjusted to maintain MAP 20% below baseline. Dexmedetomidine infusion will be stopped after graft insertion. Total dexmedetomidine consumption will be recorded.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim. Positive pressure ventilation will be set to maintain normocapnia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients with uncontrolled hypertension, coronary artery disease or on beta blockers.
- •Cerebrovascular insufficiency.
- •End stage renal failure.
- •Liver cirrhosis.
- •Patients with coagulopathy or receiving drugs influencing blood coagulation.
- •Pregnancy.
- •Known sensitivity to any of the study drugs.
- •Patients' refusal to participate in the study.
研究组 & 干预措施
Group I (control group)
Patients will be positioned supine.
干预措施: Dexmedetomidine (Drug)
Group I (control group)
Patients will be positioned supine.
干预措施: Induction and maintenance of anaesthesia (Drug)
Group II
patients will be positioned 10° anti-trendelenburg position.
干预措施: Head-Up Position (Procedure)
Group II
patients will be positioned 10° anti-trendelenburg position.
干预措施: Dexmedetomidine (Drug)
Group II
patients will be positioned 10° anti-trendelenburg position.
干预措施: Induction and maintenance of anaesthesia (Drug)
Group III
patients will be positioned 20° anti-trendelenburg position.
干预措施: Head-Up Position (Procedure)
Group III
patients will be positioned 20° anti-trendelenburg position.
干预措施: Dexmedetomidine (Drug)
Group III
patients will be positioned 20° anti-trendelenburg position.
干预措施: Induction and maintenance of anaesthesia (Drug)
结局指标
主要结局
Quality of surgical field.
时间窗: Immediately after surgery.
The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.
Surgical position accessibility.
时间窗: Immediately after surgery.
The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.
次要结局
- Recovery time(At the end of surgery)
- Sedation Score(on arrival to the PACU, then every 30 min for the first 2 hours after surgery)
- Analgesia time(first 12 hours after surgery)
- Total dexmedetomidine consumption.(At the end of surgery)
- Surgical time(At the end of surgery)
研究者
Hala Salah El-Din El-Ozairy
Principal investigator
Ain Shams University