CTRI/2025/09/095164尚未招募不适用
A single center, randomised controlled, double blinded clinical study on opioid free anaesthesia in patients undergoing minimally invasive abdominal and pelvic surgeries
SIMS Hospitals1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年10月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To compare intraoperative combination of dexmedetomidine and ketamine (ketodex) with that of intraoperative fentanyl in terms of post operative analgesia by means of Visual Analogue Scale (VAS)
研究概览
简要总结
this is a randomised controlled double blinded clinical study for the efficacy opioid free anaesthesia using a mixture of dexmedetomidine and ketamine as intraoperative infusion for the study group and intraoperative fentanyl as control group and compare the efficacy of opioid free anaesthesia and opioid anaesthesia in terms of postoperative pain and other side effects such as nausea, vomiting, confusion and emergence delirium
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
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 American society of anaesthesiology grade 1 and 2 Patients weighing between 40 and 80 kilos All genders Patients admitted for minimally invasive abdominal and pelvic surgeries Patients willing to participate in the study.
排除标准
- •Patients of American society of anaesthesiology grades 3 and above Pregnant and lactating women Patients with allergies to any of the drugs- general and local anaesthetic agents being used Patients with h/o neuromuscular disorders, malignant hyperthermia or susceptible individuals Patients with any degree of heart block or with pacemaker Minimally invasive surgeries getting converted to open surgeries Patients with anticipated possible difficult airway Patients participating in any other clinical study Patients not willing to participate in this study.
结局指标
主要结局
To compare intraoperative combination of dexmedetomidine and ketamine (ketodex) with that of intraoperative fentanyl in terms of post operative analgesia by means of Visual Analogue Scale (VAS)
时间窗: Immediate post op, every hour till 6 hours postoperative
次要结局
- To monitor & quantify adverse effects of ketodex in terms of sedation, bradycardia, hypotension & emergence delirium(To quantify efficacy of analgesia of ketodex in terms of requirement of postoperative rescue analgesia)
研究者
Dr Balachandran
SIMS Hospitals
研究点 (1)
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