Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
研究概览
简要总结
Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.
The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.
详细描述
Patients will be enrolled during the preoperative anaesthetic assessment. Premedication will be achieved with oral administration of hydroxyzine 1 mg/kg the morning before surgery.
The induction of general anaesthesia will be achieved using TARGET CONTROLLED INFUSION (TCI) of propofol associated to TCI of remifentanil or sufentanil, depending on randomization.
The conditions of endotracheal intubation will be evaluated by the Percentage Of Glottic Opening Score (POGO) and the Cormack and Lehane Score.
Mechanical volume-controled ventilation will aim to maintain normocapnia. The baseline inspiratory gas will be a mixture of 45% oxygen and 55% nitrous oxide.
Bispectral Index recording and vital signs monitoring (heart rate and arterial blood pressure) will be used to monitor the depth of anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-age between 15 and 35 years old
- •American Society of Anaesthesiologists (ASA) physical status I or II
- •Surgical removal of three to four wisdom teeth
- •general anaesthesia
- •Ambulatory surgery
排除标准
- •Obesity (Body mass index > 30 kg.m-²)
- •Pregnancy
- •Contraindication for nitrous oxide inhalation
- •Patient refusal
结局指标
主要结局
Morphine consumption in Post Anaesthesia Care Unit ( with intravenous titration given by nurse)
时间窗: 48 h after the surgery
次要结局
- - Postoperative pain (measured by the numeric pain intensity scale)(48 h after the surgery)
- tolerance of the procedure(48 h after the surgery)
- patient's satisfaction(48 h after the surgery)
- Length of stay in Post Anaesthesia Care Unit and in ambulatory surgery unit(48 h after the surgery)
- percentage of Glottic opening (POGO) score, Cormack-Lehane grading(48 h after the surgery)
- - Occurrence of postoperative nausea and vomiting(48 h after the surgery)
- additional workload for nurses(48 h after the surgery)
- postoperative analgesic requirement in the first 48 hours after surgery(48 h after the surgery)