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临床试验/CTRI/2026/01/100370
CTRI/2026/01/100370尚未招募不适用

A comparative study of intubating conditions with two different doses of cisatracurium besylate in patients undergoing general anaesthesia

BJ Medical College Ahmedabad1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月25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
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

发起方
BJ Medical College Ahmedabad
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Umesh B Jadav

B. J. Medical College , Ahmedabad

研究点 (1)

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