A comparative study of intubating conditions with two different doses of cisatracurium besylate in patients undergoing general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of intubating conditions after administration of two different doses of cisatracurium (0.15 mg/kg vs 0.20 mg/kg) for endotracheal intubation
研究概览
简要总结
General anesthesia is essential for facilitating surgeries by ensuring patient unconsciousness, analgesia, and often muscle relaxation. Endotracheal intubation is an essential component of general anesthesia, providing a secure airway and enabling controlled ventilation during surgery. Optimal intubating conditions are crucial for minimizing airway trauma, hemodynamic disturbances, and patient discomfort. Muscle relaxants play a vital role in achieving these conditions.
Succinylcholine, a depolarizing neuromuscular blocker, has traditionally been the drug of choice due to its rapid onset and short duration. However, its significant side effects—including hyperkalemia, malignant hyperthermia, increased intraocular pressure, and bradyarrhythmias—limit its use in certain patient populations. This has led to a shift toward safer non-depolarizing agents like atracurium and cisatracurium besylate.
Although atracurium is effective, its potential to cause histamine release—resulting in adverse effects such as hypotension, tachycardia, and bronchospasm—has the need for safer alternatives like cisatracurium in clinical practice.
Cisatracurium is a stereoisomer of atracurium, known for its intermediate duration of action, minimal histamine release, and organ-independent metabolism via Hofmann elimination. It is 3–4 times more potent than atracurium and demonstrates a favorable hemodynamic profile, even at higher doses. These properties make it suitable for use in patients with hepatic or renal dysfunction. The ideal dose of cisatracurium for intubation remains under evaluation, balancing between achieving optimal intubating conditions and minimizing residual neuromuscular blockade.
While the standard intubating dose is generally considered to be 2×ED95 (0.1 mg/kg), higher doses such as 0.15 mg/kg and 0.2 mg/kg have been suggested to improve intubation conditions without significantly prolonging recovery. However, comparative data between these two dosing strategies is limited.
This study is designed to evaluate and compare the intubating conditions, hemodynamic responses, and potential adverse effects of two different doses of cisatracurium besylate—0.15 mg/kg and 0.2 mg/kg—in patients undergoing general anesthesia. The results will help optimize dosing strategies for improved patient outcomes and safer anesthetic practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in ASA I and II Patients who have signed a Valid Informed written consent.
- •Patients posted for elective surgery under general anesthesia requiring endotracheal intubation.
- •Surgeries with estimated duration of 45 minutes to 3 hours.
排除标准
- •Patient refusing for consent.
- •Patients with known and anticipated difficult airway (MPC III or IV) Patients with history of Asthma.
- •Patients on antihistamine and anticonvulsants.
- •Patients with history suggestive of sleep apnea.
- •Patients with history of Gastro Esophageal Reflex Disease.
结局指标
主要结局
Quality of intubating conditions after administration of two different doses of cisatracurium (0.15 mg/kg vs 0.20 mg/kg) for endotracheal intubation
时间窗: Assessed after 180 seconds of cisatracurium administration, at the time of intubation.
次要结局
- Secondary outcomes included intraoperative hemodynamics (HR, SBP, DBP, MAP) at defined time points and perioperative/postoperative adverse effects (allergic reactions, bronchospasm, hypotension, prolonged muscle weakness, residual paralysis).
研究者
Dr Umesh B Jadav
B. J. Medical College , Ahmedabad
