Comparison of Intranasal Dexmedetomidine and Intranasal Ketamine as preemptive analgesics in patients undergoing septoplasty: A prospective randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS) pain score at the 4th postoperative hour
研究概览
简要总结
This is a prospective, randomized, double-blind clinical trial conducted at AIIMS Mangalagiri to compare the perioperative analgesic effectiveness of intranasal dexmedetomidine and intranasal ketamine as pre-emptive analgesics in adult patients undergoing septoplasty. A total of 60 patients will be enrolled and randomized into two equal groups. One group will receive intranasal dexmedetomidine 2 mcg per kg, and the other will receive intranasal ketamine 0.5 mg per kg, administered 45 to 60 minutes prior to induction of general anesthesia. The primary outcome is pain score at the fourth postoperative hour using the Numeric Rating Scale. Secondary outcomes include sedation scores, hemodynamic stability, requirement for additional analgesics, and incidence of adverse effects. The study aims to identify the more effective non-invasive pre-emptive analgesic agent for use in septoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 60 years, ASA physical status I or II, undergoing elective septoplasty under general anaesthesia at AIIMS Mangalagiri, willing to provide written informed consent.
排除标准
- •Patients aged less than 18 or more than 60 years of age, known allergy to study drugs, pregnant or lactating women, BMI more than 30 kg perm², septoplasty lasting more than 120 minutes, refusal to participate.
结局指标
主要结局
Numeric Rating Scale (NRS) pain score at the 4th postoperative hour
时间窗: primary outcome — NRS pain score — will be assessed at the 4th postoperative hour. So, the time point for the primary outcome is the 4th hour after surgery
次要结局
- Sedation score using Ramsay Sedation Scale(Preoperatively and at 1, 4, 12, and 24 hours postoperatively)
- Intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure, MAP, SpO2)(Intraoperatively every 15 minutes and postoperatively at 1, 4, 12, and 24 hours)
- Requirement of additional intraoperative analgesics
- Requirement of rescue analgesics in postoperative period
- Incidence of drug-related adverse effects(From drug administration until 24 hours postoperatively)
研究者
Dr Abin Thomas
AIIMS Mangalagiri