Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.
详细描述
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure >120% of baseline.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (18-65 years) patients
- •body mass index ≥35 kg/m2
- •scheduled for laparoscopic bariatric surgery
排除标准
- •American Society of Anesthesiologists (ASA) physical class IV,
- •severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),
- •known obstructive sleep apnea or patients with STOP-bang score ≥5,
- •baseline SpO2 <95%,
- •renal impairment,
- •allergy to any of study's drugs,
- •history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease
研究组 & 干预措施
Ketorolac group
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes
干预措施: Ketorolac group (Drug)
Ibuprofen group
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes
干预措施: Ibuprofen group (Drug)
结局指标
主要结局
VAS
时间窗: 30 minutes after extubation
Visual analogue scale
次要结局
- total intraoperative fentanyl(30 seconds after skin incision until 1 min after skin closure)
- post operative nalbuphine(30 minutes after extubation until 24 hours postoperatively)
- VAS(at 0.5, 4, 10, 18, and 24 hours after extubation)
- time to independent movement(30 minutes after extubation until 24 hours postoperatively)
研究者
Ahmed Hasanin
Principal Investigator
Cairo University