The Effect of Total Intravenous Anaesthesia With Propofol on Postoperative Pain After Third Molar Surgery: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Some of the advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, better wake up profile and a more favourable intracranial physiology. However, the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are some reasons that preclude more common use.
Postoperative dental pain produces an inflammatory pain model. Since propofol has anti-inflammatory effects, it may have significant analgesic effects in patients undergoing dental surgery. To the best of our knowledge, there are no randomized controlled trials comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative pain scores, analgesic consumption, and adverse effects in patients undergoing dental surgery. This will help determine whether propofol may be a useful analgesic adjunct in dental surgery.
详细描述
Preoperative care
Assessment will be done at the preadmission clinic or at the general ward. Fasting for patients will start at midnight before operation. Sedative premedication will not be prescribed.
Anaesthesia and intraoperative care
Group S
Patients from group S will be anaesthetized according to the following protocol:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will not be informed about what type of anaesthesia they will receive. A separate investigator assessing the patients for data collection after the operation will be blinded. The anaesthetist providing general anaesthesia will not be involved in data collection.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I to III
- •Age 18 to 80 years old
- •Scheduled for elective extraction of impacted bilateral third molar teeth under general anaesthesia in Queen Mary hospital.
排除标准
- •Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol.
- •Alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- •Patients with liver dysfunction (Plasma bilirubin over 34 micromol/L, INR over 1.7, ALT and AST over 100U/L)
- •Impaired or retarded mental state
- •BMI > 35kg/m2
- •History of chronic pain
- •Pregnancy
- •Local infection
- •Patient refusal
研究组 & 干预措施
Group S
Patients will be anaesthetized by inhalational anaesthesia using sevoflurane.
干预措施: Sevoflurane (Drug)
Group P
Patients will be anaesthetized using total intravenous propofol.
干预措施: propofol (Drug)
结局指标
主要结局
pain score
时间窗: up to postoperative day 3
measure pain scores at rest and mouth opening using numeral rating scale
次要结局
- analgesic consumption(up to postoperative day 3)
- presence of persistent pain(3 months after surgery)
- side effects of analgesics used(up to postoperative day 3)
- intraoperative vital signs(during surgery)
- severity of persistent pain(3 months after surgery)
研究者
Wong Sau Ching Stanley
Clinical Assistant Professor
The University of Hong Kong