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临床试验/CTRI/2022/01/039588
CTRI/2022/01/039588尚未招募不适用

Comparison of Hemodynamic changes in patients undergoing Laparoscopic Cholecystectomy using Rocuronium and Vecuronium for intubation and maintenance under General Anesthesia

Teerthanker Mahaveer Medical College and Research Centre Moradabad UP1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022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
100
试验地点
1
主要终点
To note the ease of intubation and any hemodynamic changes with respect to heart rate, blood pressure, MAP.

研究概览

简要总结

Laparoscopic Cholecystectomy is a gold standardprocedure for management of gall bladder stones and is usually performed undergeneral anaesthesia. The procedure offers several advantages over opentechnique like reduction of stress response of surgery, decrease inpost-operative pain, decrease chances of wound infection and faster recoverywith good cosmetic appearance. Major disadvantages are due to physiological effectsof insufflation of CO2 in the abdomen. Neuromuscular blocking agents are useful in performing endotracheal intubation andproviding surgical relaxation. The onset time, duration of muscle relaxationand type of surgery are major factors that determine the choice of musclerelaxant to be used for the endotracheal intubation and surgical relaxation. Vecuroniumwas the first non-depolarizing neuromuscular blocking agent with anintermediate duration of action to be introduced into clinical practice. With botha shorter duration of action and minimum hemodynamic side effects, it seta standard against which all subsequent neuromuscular blocking agents werecompared. Rocuronium,a non depolarising muscle relaxant, was first introduced and marketed in the UnitedStates. It is known for its rapid onset and intermediate duration of action.  Added advantage of Rocuronium is the rapidonset and it is excreted unchanged in urine, hence eliminating the side effectscaused by the metabolites.

AIM**:** Comparison of hemodynamic changes in patientsundergoing Laparoscopic  Cholecystectomyusing Rocuronium and Vecuronium for intubation and maintenance under generalanaesthesia.

OBJECTIVES**:**

1.Tomeasure intubating condition

2.Tomeasure hemodynamic changes during intubation

3.Tomeasure hemodynamic changes during maintenance of general anaesthesia.

4.Torecord complications, if any.

The study will be conducted after obtaining clearance from the Institutional Ethical Committee and written informed consent from the patients. patients will be explained about the drugs being used in the in their own language and will also be explained that they can belong to either of the two groups. patients will be randomly divided in two groups by "chit and box" method. Control group will be given injection vecuronium 0.1mg/kg and study group will be given injection rocuronium 0.6mg/kg.

Intubatingconditions will be graded and assessed according to scoring of endotrachealintubating conditions by Cooper et al. Hemodynamic parameters : Heart rate,Blood Pressure, MAP and SPO2 will be recorded timely. Statisticalanalysis will be done using appropriate test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) grade I and II scheduled for surgery under general anesthesia.
  • Patients with BMI of 18.5-22.9 kg/m2.

排除标准

  • Patients undergoing surgery with moderate to severe blood loss.
  • Patients who are allergic to pre-treatment or study drugs.
  • Systemic disorders like cardiovascular , pulmonarv, hepatorenal, metabolic diseases.

结局指标

主要结局

To note the ease of intubation and any hemodynamic changes with respect to heart rate, blood pressure, MAP.

时间窗: After muscle relaxant, before intubation, 1 and 5 minute after intubation, before skin incision, 1 minute after skin incision,before carboperitoneum, 1 minute after carboperitoneum, 1 , 5, 10, 15, and 20 minutes after giving the drug, before extubation and 1minute and 5 minute after extubation

次要结局

  • To look for any complications such as arrhythmias, ischemic changes or hypotension(at every 5 mins after induction and every 5 mins post extubation for upto 30 mins)

研究者

发起方
Teerthanker Mahaveer Medical College and Research Centre Moradabad UP
申办方类型
Private medical college

研究点 (1)

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