Intraoperative Dexmedetomidine Versus Ketamine-Dexmedetomidine Infusion For Postoperative Analgesia In Major Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ILBS
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the postoperative fentanyl consumption for the first 24 hours using IV PCA in following two groups of patients undergoing major abdominal surgery
研究概览
简要总结
Effective amelioration of pain following major abdominal surgery remains a fundamental challenge. Acute postoperative pain after abdominal surgery can be a significant problem because it has been shown to alter the metabolic response, delayed recovery with a longer stay and increased morbidity, as well as the development of a chronic pain
The intrinsic antinociceptive and anti-hyperalgesia properties of dexmedetomidine reportedly reduces postoperative opioid consumption.
Perioperative ketamine has a consistent opioid-sparing effect, minimizes the development of tolerance, and reduces the postoperative pain scores
Several pharmacological options exist for adequate perioperative pain management. However, each drug has its pros and cons limiting its broad applicability.
Opioids remain the cornerstone of perioperative analgesia but they produce numerous side effects, including respiratory depression,postoperative hyperalgesia, nausea, vomiting, ileus, and urinary retention
To the best of our knowledge, no study has assessed the postoperative analgesia produced by the simultaneous use of ketamine and dexmedetomidine (ketodex infusion) as intraoperative anesthetic adjuvants.
Multimodal approach to perioperative analgesia is recommended in clinical guidelines and is essential to Enhanced Recovery After Surgery (ERAS) clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA class 1 & 2.
排除标准
- •Patient refusal Contraindication to study drugs History of drug abuse Insufficient comprehension to use of PCA ASA class 3 & 4.
结局指标
主要结局
To compare the postoperative fentanyl consumption for the first 24 hours using IV PCA in following two groups of patients undergoing major abdominal surgery
时间窗: Post Operative 24hr
Group A – Intraoperative IV dexmedetomidine infusion
时间窗: Post Operative 24hr
Group B – Intraoperative IV ketodex infusion
时间窗: Post Operative 24hr
次要结局
- To compare the intraoperative anesthetic requirements(End of Surgery)
- To compare the intraoperative fentanyl requirements(End of surgery)
- To compare the postoperative pain scores using NRS(0,2,4,12,24hrs)
- To compare the time of first rescue analgesia requirement(Post Operative)
- To record incidence of post operative nausea and vomiting(Post Operative)
- To record incidence of post operative delirium using CAM ICU score(post operative)
- - To compare the postoperative sedation score using the Modified Ramsay Sedation Scale(MRSS)(postoperative)
- To compare the intraoperatively hemodynamic parameters(15mins)
研究者
Dr Shreem Rawal
Institute of Liver and Biliary Sciences