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临床试验/CTRI/2025/10/096295
CTRI/2025/10/096295尚未招募2/3 期

Comparison of efficacy between Esmolol IV vs Lidocaine IV in attenuation of haemodynamic stress response during laryngoscopy and endotacheal intubation in laparoscopic surgeries

Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Changes in Systolic and Diastolic Blood Pressures, Pulse Rate, Oxygen Saturation

研究概览

简要总结

Efficacy of Esmolol IV & Lidocaine IV in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries is being studied. Objective is to study the Efficacy of Esmolol IV & Lidocaine IV in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries.

 INCLUSION CRITERIA

·         Patients willing to sign informed consent

·         Male or Female patients between 18 to 60 years of age

·         Patients belonging to American Society of Anaesthesiologists(ASA) physical status I & II

·         Patients posted for elective laparoscopic surgeries under general anaesthesia.

 EXCLUSION CRITERIA

·         Patients unwilling to participate in study.

·         Patients with Body Mass Index > 29 Kg/m^2

·         Patients with cerebrovascular diseases, hepatic and/or renal diseases

·         Psychiatric patients

·         Pregnancy and lactating women

·         Patients belonging to American Society of Anaesthesiologists (ASA) III and above.

 We will be conducting this study on 72 adults aged 18-60 years belonging to grade I &  II American Society of Anaesthesiologists classification who will undergo laparoscopic surgeries under general anaesthesia. They will be divided into 2 equal groups by chit method. Group E will receive Inj. Esmolol 2 mg/kg 3 minutes prior to intubation. Group L will receive Inj. Lidocaine 2 mg/kg 3 minutes prior to intubation. The intervention will be performed by Consultant Anaesthesiologist prior to intubation.

 Haemodynamic parameters are measured

  1. Three minutes Before administration of test drugs (baseline)

  2. After administration of test drugs

  3. At laryngoscopy & endotracheal intubation

  4. After intubation at 1st, 3rd, 5th & 7th minutes.

 Site of study: Dept of anaesthesiology, S.B.K.S. Medical Institute & Research centre, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat

 Study Design: Prospective Randomised consoled study

Study Duration: The study will be initiated after obtaining permission from institutional ethical committee till the achievement of the sample size or 1 year after the approval from ethical committee (whichever is earlier)

 Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value

 Likely outcome: This prospective and comparative study will help us to compare the efficacy between  Esmolol and Lidocaine on haemodynamic stress response during laryngoscopy & endotracheal intubation in patients undergoing cardiovascular surgeries by having better outcome in haemodynamics.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc

入排标准

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

入选标准

  • 1.Patients willing to sign informed consent 2.Male or Female patients between 18 to 60 years of age 3.Patients belonging to American Society of Anaesthesiologists(ASA) physical status I & II 4.Patients posted for elective laparoscopic surgeries under general anaesthesia.

排除标准

  • 1.Patients unwilling to participate in study.
  • 2.Patients with Body Mass Index more than 29 Kg per metre square 3.Patients with cerebrovascular diseases, hepatic and/or renal diseases 4.Psychiatric patients 5.Pregnancy and lactating women 6.Patients belonging to American Society of Anaesthesiologists (ASA) III and above.

结局指标

主要结局

Changes in Systolic and Diastolic Blood Pressures, Pulse Rate, Oxygen Saturation

时间窗: 1) Three minutes prior to laryngoscopy and endotracheal intubation - recorded as baseline | 2. During laryngoscopy and endotracheal intubation | 3. One minute after laryngoscopy and endotracheal intubation | 4. Three minutes after laryngoscopy and endotracheal intubation | 5. Five minutes after laryngoscopy and endotracheal intubation | 6. Seven minutes laryngoscopy and endotracheal intubation | 7. Nine minutes after laryngoscopy and endotracheal intubation

次要结局

未报告次要终点

研究者

发起方
Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anupam B Balawan

Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,

研究点 (1)

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