A study to compare intravenous dexmedetomodine with intravenous preservative free lignocaine for attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation
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 study hemodynamic response during laryngoscopy and endotracheal intuabtion
研究概览
简要总结
A STUDY TO COMPARE INTRAVENOUS DEXMEDETOMIDINE WITH INTRAVENOUS PRESERVATIVE FREE LIGNOCAINE FOR ATTENUATION OF HEMODYNAMIC RESPONSES TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION
AIM: The aim of the study will be to compare intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine for attenuation of hemodynamic response during laryngoscopy and endotracheal intubation.
OBJECTIVE:
1.To compare heart rate using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia.
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To compare systolic blood pressure, diastolic blood pressure and mean arterial blood pressure using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia.
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To compare Spo2 using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia
INCLUSION CRITERIA:
Patients willing to sign written & informed consent.
Male or female patients between ages of 18 to 55 years.
Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
Patients posted for elective surgeries under general anaesthesia.
EXCLUSION CRITERIA:
Patients unwilling to participate in the study.
Patients with cardiovascular, cerebrovascular, hepatic and renaldiseases.
Patients having arrhythmias or heart block.
Psychiatric patients.
Pregnancy & lactating women.
Patients taking beta blockers.
History of allergy to the study drugs.
BMI >30
Patients with ASA physical status III and above.
Patient with suspected difficult airway and mallampatti Grade III and IV.
We will be conducting this study on 30 adults aged 18-60 years belonging to grade I & II of American Society of Anesthesiologists (ASA) classification who will undergo elective surgeries under general anaesthesia. They will be randomly allocated using computer generated random numbers into 2 groups Group D and Group L of 30 patients each:
Group D (n=30): Patients will receive intravenous dexmedetomidine (1mcg/kg) in 100ml normal saline over 15-20 minutes 5 minutes before induction of general anaesthesia.
Group L (n=30): Patients will receive intravenous preservative free 2% lignocaine (1.5 mg/kg) 5 minutes before induction of general anaesthesia.
Drugs will be administered by the consultant Anesthesiologist present in the operation theatre.
Monitoring of parameters i.e. HR, SBP, DBP, MAP, SPO2 will be noted by me at baseline, after administration of test drug, after induction, during laryngoscopy and intubation and at 1,3,5 minutes after intubation.
Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Instituteand Research Centre, Piparia, Waghodia, Vadodara, Gujarat.
Study Design- Prospective and Comparative Study
Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee for duration of 18 months.
SAMPLE SIZE : 60 patients
Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency andpercentage. As regard to numerical variables; tests like unpaired student “t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables; chi “square test will be used. p value <0.05 will be considered statistically significant.
Likely outcome/ Benefit of the study: This prospective and comparative study will help us to compare the efficacy between two different doses of intravenous Dexmedetomidine in attenuating hemodynamic responses to laryngoscopyand endotracheal intubation inpatients undergoing surgeries under generalanaesthesia and will enable us to know which dose of the dexmedetomidine drug is most beneficial in giving balanced general anaesthesia by having better outcomes in hemodynamics.
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 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients willing to give written and informed consent male and females of age group 18 to 55 years of age patients belonging to ASA physical status 1 and 2 patients posted for elective surgeries under general anaesthesia.
排除标准
- •patients unwilling to participate in the study patients with crdiovascular, cerebrovascular, hepatic and renel diseases patients having arrhytmias or heart block psychiatric patients pregnancy and lactating patients patients taking beta blockers history of allergy to the study drugs BM!
- •more than 30 patients with ASA physical status of 3 and above patients with suspected difficult airway and Mallampatti grade 3 and 4.
结局指标
主要结局
to study hemodynamic response during laryngoscopy and endotracheal intuabtion
时间窗: baseline | after administration of the test drug | after induction | at laryngoscopy and intubation | at 1 min after intubation | at 3 mins after intubation | at 5 mins after intubation
次要结局
- to study sedation status using RAMSAY sedation score(post operatively for every 30 minutes till RAMSAY sedation score of 2 is achieved)
研究者
Harsh Rathod
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre
