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临床试验/CTRI/2025/02/080438
CTRI/2025/02/080438尚未招募2/3 期

Fentanyl-clonidine & fentanyl-lidocaine on attenuation of hemodynamic stress response to laryngoscopy and tracheal intubation in cardiovascular surgery - A comparative study

Smt. Bhikhiben Kanjibhai Shah Medical Institute and research centre1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年2月25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
To study Haemodynamic response during Laryngoscopy & endotracheal intubation

研究概览

简要总结

Efficacy of Fentanyl-Clonidine & Fentanyl-Lidocaine in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries  is being studied.

 Objectiveis to study the Efficacy of Fentanyl-Clonidine & Fentanyl-Lidocaine 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, & III

·       Patients posted for elective cardiovascular surgeries under general anaesthesia.

·       Patients with ejection fraction more than or equal to 40%

 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) 4 and above.

·       Patients with ejection fraction less than 40%.

 We will be conducting this study on 72 adults aged 18-60 years belonging to grade I, II & III American Society of Anaesthesiologists classification who will undergo elective cardiovascular surgeries under general anaesthesia. They will be divided into 2 equal groups by chit method.

 Group FCwill receive Inj. Fentanyl 2 mcg/kg & Inj. Clonidine 2 mcg/kg 3 minutes prior to intubation.

Group FL will receive Inj. Fentanyl 2 mcg/kg & Inj. Lidocaine 1.5 mg/kg 3 minutes prior to intubation.

The intervention will be performed by Consultant Anaesthesiologist prior to intubation.

 Haemodynamic parameters are measured

1.     Before administration of test drugs (baseline)

2.     After administration of test drugs

3.      After induction

4.     At laryngoscopy & endotracheal intubation

5.     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 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 <0.05 will be considered statistically significant. between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant.

**Likely outcome:**This prospective and comparative study will help us to compare the efficacy between Fentanyl-Clonidine & Fentanyl-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
盲法
Participant and Investigator 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

  • 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, & III 4) Patients posted for elective cardiovascular surgeries under general anaesthesia.
  • Patients with ejection fraction more than or equal to 40%.

排除标准

  • Patients unwilling to participate in the study 2) Patients with Body Mass Index more 29 kg per meter 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) 4 and above.
  • Patients with ejection fraction less than 40%.

结局指标

主要结局

To study Haemodynamic response during Laryngoscopy & endotracheal intubation

时间窗: 1) At baseline | 2) After test drug administration | 3) After Induction | 4) At Laryngoscopy and Endotracheal intubation | 5) After intubation at 1st, 3rd, 5th and 7th minutes

次要结局

  • To study Sedation Score after extubation or any side effects(1) Immediately after extubation)

研究者

发起方
Smt. Bhikhiben Kanjibhai Shah Medical Institute and 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. Bhikhiben Kanjibhai Medical Institute and research centre

研究点 (1)

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