Comparison of efficacy between Esmolol IV vs Lidocaine IV in attenuation of haemodynamic stress response during laryngoscopy and endotacheal intubation in laparoscopic surgeries
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
-
Three minutes Before administration of test drugs (baseline)
-
After administration of test drugs
-
At laryngoscopy & endotracheal intubation
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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
Dr Anupam B Balawan
Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,
