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临床试验/CTRI/2024/07/070232
CTRI/2024/07/070232尚未招募Unknown

Study to compare time taken to intubate with Videolaryngoscopy versus Conventional laryngoscopy in adult patients undergoing Surgery under General Anesthesia- Prospective randomized study at SMS medical college and attached group of hospital, Jaipur

Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospitals1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
1.Mean Total Intubation time in Seconds

研究概览

简要总结

Direct laryngoscopy is most widely used method of oro-tracheal intubation but at times it could be difficult, and may lead to adverse effect on cardiovascular system. Video laryngoscopy in contrast provides better visualization of airway making oro-tracheal intubation easy. In this study we will compare the use of Video laryngoscope (Group A) versus the macintosh (direct) laryngoscope blade (Group B) for routine airway management. 88 ASA grade 1 and grade 2 patients between the age of 18 and 60 yrs scheduled for elective laparoscopic cholecystectomy surgery will be included in the study. Informed written consent will be taken in the vernacular language. Premedication with injection (Inj) glycopyrolate 0.2 mg intravenous(i.v) 10 mins before + Inj. midazolam 0.02mg/kg i.v. 10 mins and (inj) metoclopramide 10mg i.v. 10mins before  + injection fentanyl 2mcg/kg i.v. will be given. All the patients will be preoxygenated with 100% oxygen through a face mask for three minutes, then general anesthesia will be induced with intravenous administration of inj. propofol (2 mg/kg), and inj Succinylcholine (2 mg/kg) Then patients will be randomly divided into 2 groups. Group  A (n=44) will be intubated using video laryngoscope (indirect) and Group B (n=44) will be intubated using direct laryngoscope (Macintosh) In the group A, an intubating stylet will be used. The oro-tracheal intubation will be carried out. Time taken for tracheal intubation procedure, visualization of airway, Haemodynamic parameters (Systolic BP, diastolic BP, mean arterial pressure, heart rate) will be assessed at numerous intervals as follow: baseline, after induction of anesthesia, one and five minutes after intubation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients undergoing elective Surgery under General Anaesthesia.
  • 2.Patients having American Society of Anesthesiologist (ASA) physical status I and II..
  • 3.Patients consenting to participate.
  • 4.Patients with Mallampati grade 1 or 2.

排除标准

  • 1.Patient refusal.
  • 2.Patient should not be a part of other study 3.Patient with anticipated difficult intubation 4.Patients having oxygen saturation less than 92% after bag and mask ventilation with 100% oxygen 5.Patient with known risk of Aspiration 6.Emergency surgery.

结局指标

主要结局

1.Mean Total Intubation time in Seconds

时间窗: 1. Baseline | 2. After Induction | 3. 1min after induction | 4. 5 min after induction

2.Mean Ease of intubation score

时间窗: 1. Baseline | 2. After Induction | 3. 1min after induction | 4. 5 min after induction

3.Mean Modified Cormack Lehane grading

时间窗: 1. Baseline | 2. After Induction | 3. 1min after induction | 4. 5 min after induction

5.Mean Haemodynamic parameters :Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Heart Rate(HR)

时间窗: 1. Baseline | 2. After Induction | 3. 1min after induction | 4. 5 min after induction

次要结局

  • N/A(N/A)

研究者

发起方
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospitals
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Harpreet Kaur

Sawai Man Singh Medical College and attached Hospitals

研究点 (1)

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