Sedative and Analgesic Effects of Dexmedetomidine Versus Ketamine in Patients Undergoing Varicocelectomy Under Spinal Anaesthesia: A Prospective Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- the time required in minutes to achieve OAA/S score 4.
研究概览
简要总结
The demand for safe and effective sedation during spinal anesthesia has increased in recent years, particularly in ambulatory and minor surgical procedures. The ideal sedative agent should provide adequate anxiolysis and comfort, maintain cardiorespiratory stability, and allow rapid recovery without significant adverse effects .
Ketamine, a phencyclidine derivative, produces sedation, analgesia, and amnesia while maintaining airway reflexes and spontaneous respiration. However, it is often associated with undesirable psychomimetic reactions and sympathetic stimulation, including tachycardia and hypertension .
In contrast, dexmedetomidine, a highly selective α2-adrenergic agonist, provides cooperative sedation, analgesia, and reduced anesthetic requirements, but it may cause bradycardia and hypotension, particularly at higher doses .
The combination of ketamine and dexmedetomidine (often referred to as "Ketadex") has recently gained attention due to its synergistic effects. Evidence suggests that this combination improves hemodynamic stability, decreases emergence agitation, and provides superior analgesia compared to either agent alone [4,5]. Moreover, ketamine counteracts the bradycardia and hypotension induced by dexmedetomidine, while dexmedetomidine mitigates ketamine-induced psychomimetic side effects .
Despite these advantages, the optimal dosing regimen and comparative efficacy of the two drugs when used individually remain subjects of clinical debate. Recent randomized controlled trials comparing intravenous dexmedetomidine and ketamine during spinal anesthesia reported differences in sedation quality, hemodynamic stability, and recovery profile . Therefore, this study aims to compare the sedative and hemodynamic effects of intravenous dexmedetomidine versus ketamine infusion in patients undergoing varicocelectomy under spinal anesthesia.
the study aim to Compare sedative, analgesic efficacy, and safety profile of intravenous dexmedetomidine versus ketamine in patients undergoing varicocelectomy under spinal anaesthesia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: from 18 to 40 years
- •Sex: Male patients
- •Operation: varicocelectomy under spinal anesthesia
- •ASA physical states I-II
排除标准
- •Psychiatric or neurological disorders
- •Respiratory disorders
- •Cardiovascular disorders
- •Coagulation disorders
- •Contraindications to neuraxial block (allergy to L.A, peripheral issues)
- •spine deformity
研究组 & 干预措施
Group A
patiets received Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Group B
patients receive Ketamine
干预措施: Ketamine (0.5 mg/kg) (Drug)
结局指标
主要结局
the time required in minutes to achieve OAA/S score 4.
时间窗: 24 hour
Modified observer's assessment of alertness/sedation score (OAA/S): 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking 1 Responds only after painful stimulus 0 No response even after painful stimulus
次要结局
未报告次要终点
研究者
Mohamed khalifa Mahmoud Saleh
residant doctor at Assiut university hospital
Assiut University