qNOX guided versus standard care intraoperative analgesia during fentanyl-propofol anaesthesia in patients undergoing laparoscopic and robotic intraabdominal surgeries- a non inferiority RCT
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparing the total opioid requirement in intraoperative period and in first hour of post operative period after extubation in patients receiving qNOX-guided fentanyl titration versus those receiving conventional fentanyl administration
研究概览
简要总结
The enrolled patients will be randomized by computer-based system into 2 groups – Group A and Group B. In Group A, qNOX guided intraoperative fentanyl boluses will be given, while in Group B, fentanyl boluses will be given in response to tachycardia and hypertension or as per discretion of anaesthesiologists. Comparison of the total opioid requirement in intraoperative period and in first hour of post operative period after extubation in patients receiving qNOX-guided fentanyl titration versus those receiving conventional fentanyl administration will be done. Also the post operative pain scores (0-10 Verbal Response Scale) after extubation in patients receiving qNOX guided fentanyl titration versus those receiving conventional fentanyl administration will be compared along with Modified Aldrette Score at every 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of ages 18 years to 70 years of either sex belonging to ASA I to III and Scheduled to undergo elective laparoscopic and robotic intraabdominal surgeries under general anaesthesia expected to last >2 hours.
排除标准
- •Patients requiring TIVA for nerve monitoring ii.
- •Patients who do not have regional or neuraxial blocks iii.
- •If a different intraoperative opioid than fentanyl is preferred by doctors.
- •Patients with neurologic conditions who also use psychotropic medications that may make it difficult to accurately estimate postoperative pain v.
- •Chronic opioid user vi.
- •BMI > 40 kg/m2 vii.
- •Refusal to give consent.
结局指标
主要结局
Comparing the total opioid requirement in intraoperative period and in first hour of post operative period after extubation in patients receiving qNOX-guided fentanyl titration versus those receiving conventional fentanyl administration
时间窗: Opioid given during intraoperative period; during first 60 min in post op
次要结局
- i. To compare the pain scores (0-10 Verbal Response Scale) after extubation in patients receiving qNOX guided fentanyl titration versus those receiving conventional fentanyl administration(ii. Time for emergence from anesthesia—the time between the end of inhalational anaesthesia and extubation)
研究者
Dr. Manoj Kamal
All India Institute of Medical Sciences Jodhpur