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临床试验/CTRI/2024/11/076818
CTRI/2024/11/076818尚未招募3 期

A comparative study of efficacy of atracurium and cisatracurium for hemodynamic stability in patients undergoing laparoscopic surgeries

MGM Medical College and Hospital Aurangabad1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To compare the hemodynamic parameters between cisatracurium and atracurium

研究概览

简要总结

Laparoscopic surgeries are done very commonly nowadays in every part of the world. They have many advantages compared to open procedures like less surgical trauma, less intraoperative and postoperative pain which would result in early ambulation and discharge, thus reducing duration and cost of hospital stay.However, Surgical stress responses during laparoscopic surgeries may be as strong as in open surgeries due to creation of pneumoperitoneum by carbon dioxide.It may lead to alteration in acid base balance, cardiovascular and pulmonary physiology. The introduction of nondepolarizing neuromuscular blocking agents has helped overcome most of these adverse effects making the administration of neuromuscular blockade comparatively safer. Neuromuscular blocking drugs interrupt transmission of nerve impulses at neuromuscular junction thus aid endotracheal intubation, mechanical ventilation, decrease anaesthetic requirement, prevent patient movement, facilitate surgery and decrease oxygen consumption by reducing the work of breathing.(4,5) Vecuronium and Atracurium are commonly used NMBAs in General Anaesthesia.Atracurium is preferred in patients with renal failure and does not affect intracranial or intraocular pressure. However, it has the potential to cause histamine release. Cisatracurium, a purified stereoisomer of atracurium, is similar to it in almost all aspects but is not associated with histamine release in humans. So it can be helpful in maintaining hemodynamic stability.  So we decided to compare hemodynamic characteristics of atracurium and cisatracurium. Apart from neuromuscular blockers, other medications like alpha2 agonists- Dexmeditomidine,  nitroglycerine  a venodilator, beta blockers and opioids are used to provide hemodynamic stability during pneumoperitoneum created for laparoscopic surgeries.  There are some previous studies which have compared Atracurium and Cisatrcurium for maintaining hemodynamic stability in general anaesthesia other than laparoscopic surgeries. Our primary outcome is to compare hemodynamic characteristics and secondary outcome is to observe requirement of vasoactive agents (vasopressors and vasodilators) in intraoperative period, complications like erythema, hypotension, bronchospasm between the two groups.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA GRADE 1 and 2 Patients undergoing elective laparoscopic surgeries.

排除标准

  • Patients with known hypersensitivity to neuromuscular blocking agents, BMI more than 30, patiets on beta blockers,patients on antipsychotics.

结局指标

主要结局

To compare the hemodynamic parameters between cisatracurium and atracurium

时间窗: 1 Baseline after the patient is shifted to Ot table | 2 Immediately after administering NMBA | 3 Immediately after Intubation | 4 5 minutes after Intubation | 5 Just before creation of pneumoperitoneum | 6 Every 10 minutes till the completion of surgery | 7 After desufflation | 8 At extubation

次要结局

  • To observe requirement of vasoactive agents inintraoperative period, complications like erythema, hypotension,bronchospam between the two groups(Baseline after the patient is shifted to Ot table)

研究者

发起方
MGM Medical College and Hospital Aurangabad
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Harshada

MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD

研究点 (1)

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