跳至主要内容
临床试验/CTRI/2024/07/070575
CTRI/2024/07/070575尚未招募不适用

A Comparative Study between ambu laryngeal mask airway And Baska Laryngeal Mask Airway in patients undergoing minor surgery under General Anaesthesia - A Prospective Randomized control Trial

Dr Suja R1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月23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
60
试验地点
1
主要终点
To compare the hemodynamic changes such as 1. Heart rate 2. systolic BP 3. diastolic BP

研究概览

简要总结

Pre anesthetic checkup will be done and those patients who fit into the inclusion criteria will be taken up for the study. Study will be started after ethical committee and institutional committee approval .

• NPO of 6 hours for solid foods and 4 hours for liquids will be ensured in all the patients. They would be pre medicated with Tab. Alprazolam 0.5 mg the night before surgery followed by Inj. Pantoprazole 40 mg IV on the morning of surgery. IV access with 18G venflon secured in all patients. Monitors- Pulse oximeter, NIBP, ECG. ETCO2, Baseline values will be noted.

• Group 1 includes the BASKA LMA insertion • Group 2 includes the AMBU LMA insertion • Patients will be monitored for the following • Blood pressure and heart rate will be monitored noninvasively. • Ease of intubation, number of attempts needed for placement of airway, time taken for insertion, Airway leak pressure is determined by closing the expiratory valve of the circle system at a fixed gas flow and recording the oropharyngeal leak pressure by detection of an audible noise using a stethoscope placed just lateral to the thyroid cartilage.

• Intra and postoperative complications if any will be noted

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA 1 and ASA 2 patients undergoing minor surgery.

排除标准

  • 1.Surgery extending more than 45 minutes.
  • 2.BMI ˃ 30kg/m2 3.Emergency procedures 4.Pregnancy 5.History of COPD, bronchial asthma.
  • •History of gastro esophageal reflux disease.

结局指标

主要结局

To compare the hemodynamic changes such as 1. Heart rate 2. systolic BP 3. diastolic BP

时间窗: At 0,1,3,5,10 minutes

4.Mean arterial pressure between the two groups.

时间窗: At 0,1,3,5,10 minutes

次要结局

  • compare the 1.ease of insertion 2.time taken and(3. the number of attempts for insertion between the two groups.)

研究者

发起方
Dr Suja R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Suja R

Shri Sathya Sai Medical College And Research Institute

研究点 (1)

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