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临床试验/CTRI/2025/02/079980
CTRI/2025/02/079980尚未招募3 期

COMPARISON OF PROTECTOR LMA AND ENDOTRACHEAL TUBE IN PATIENT UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY: A RADOMISED CONTROLLED TRIAL.

Dr Lakesh k Anand1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月14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
96
试验地点
1
主要终点
Hemodynamic response (Heart rate and Blood pressure)

研究概览

简要总结

Laparoscopic cholecystectomy is one of the commonly performed surgical procedure under general anaesthesia and is considered procedure of choice for cholelithiaisis. It is minimally invasive procedure that involves insufflation of the abdominal cavity with carbon dioxide. Laparoscopic cholecystectomy faces other challenges to anesthesiologist caused by increased intraabdominal pressure and abdominal distention due to pneumoperitoneum, compromised ventilation due to distended abdomen pushing diaphragm into thoracic cavity causing unfavorable hemodynamic response.  Control of Heart rate and blood pressure are important aspect to the anesthesiologist for the benefit of the patient. The Endotracheal intubation has been considered as an ideal approach, However it has disadvantages like raised respiratory and hemodynamic response during intubation, pneumoperitoneum and extubation. post operative sore throat is also serious concern to prevent these complications laryngeal mask airway can be used as an alternative to endotracheal intubation for airway management and laparoscopic surgeries. Amongst the supraglottic airway devices the LMA Protector is the most advanced, airway device available from teleflex. LMA Protector studied in Laparoscopic surgeries showed High oropharyngeal leak pressure and it could achieve effective ventilation and shown to be safe and effective in patients undergoing laparoscopic surgery.

Very limited literature is available regarding the use of LMA protector in laparoscopic surgery .Hence the present study is to compare the effectiveness of LMA Protector with ETT in patients undergoing laparoscopic cholecystectomy under general anesthesia while comparing hemodynamic response (Heart rate and blood pressure) and postoperative laryngopharyngeal morbidity( Sore throat and dysphagia).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I-II, Patients undergoing elective laparoscopic cholecystectomy surgeries requiring General anaesthesia.

排除标准

  • 1.Patients with a body mass index (BMI)more than 35 kg per meter square.
  • 2.Patients with increased risk of regurgitation and aspiration of gastric content 3.Patients with distorted airway anatomy 4.Patients with upper respiratory tract infection 5.Patients with hepatic or renal insufficiency 6.Pregnant patients 7.Patients unable to understand the study protocol 8.Refusal of consent.

结局指标

主要结局

Hemodynamic response (Heart rate and Blood pressure)

时间窗: Hemodynamic response (Heart rate and Blood pressure) will be recorded at fixed time intervals Preinduction, after induction with the LMA Protector or ETT, before pneumo-peritoneum 1, 5, 10 minutes after pneumoperitoneum after release of pneumoperitoneum during extubation and postoperatively at 0 hour (when patient is conscious, oriented and able to comprehend) and at 24 hours.

次要结局

  • Postoperative laryngopharyngeal morbidity (Sore throat & dysphagia)(Post extubation & after 24 hours)

研究者

发起方
Dr Lakesh k Anand
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashutosh Ashok Mishra

MM Institute of Medical Science and Research,Mullana,Ambala

研究点 (1)

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