Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain score for 48 hours
研究概览
简要总结
This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
详细描述
Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice.
Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes .
Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo .
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
- Triple (Participant, 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
- •Age group: 18-65 years old
- •American Society of Anesthesiologists (ASA )class I and II
- •Indicated laparoscopic bariatric surgery
排除标准
- •Renal, hepatic or cardiac insufficiency
- •Positive pregnancy test
- •Alcohol or drug abuse
- •Psychiatric disease
- •History of chronic pain
- •Allergy or contraindication to any of the study drugs
研究组 & 干预措施
Opioid Based Anesthesia
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl and Sevoflurane.
干预措施: Opioid based anesthesia Fentanyl and Remifentanyl (Drug)
Opioid Free Anesthesia
General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine and Sevoflurane.
干预措施: Opioid free Anesthesia dexmedetomidine and lidocaine (Drug)
结局指标
主要结局
Postoperative pain score for 48 hours
时间窗: 48 hours postoperative
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 and every 6 hours up to 48 hours post surgery.
次要结局
- Postoperative morphine consumption at the surgical ward for 48 hours(48 hours postoperative)
- Postoperative morphine Side effects: Sedation score .for 48 hours(48 hours postoperative)
- Postoperative morphine Side effects:Respiratory depression for 48 hours(48 hours postoperative)
- Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)(2 hours postoperative)
- Postoperative morphine Side effects: Nausea vomiting for 48 hours(48 hours postoperative)
- Postoperative morphine Side effects: Itching for 48 hours(48 hours postoperative)
研究者
Hanane Barakat
MD
Lebanese American University