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临床试验/CTRI/2025/02/080072
CTRI/2025/02/080072尚未招募不适用

A Prospective study to compare the efficacy to compare the efficacy of two different doses of intravenous Dexmedetomidine in attenuating the hemodynamic responses during laryngoscopy and endotracheal intubation.

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月28日最近更新:

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 check efficacy of dexmedetomidine for blunting hemodynamic resonse during laryngoscopy and intubation via intravenous route in two different doses

研究概览

简要总结

A prospective study to compare to compare the efficacy of two different doses of intravenous dexmedetomidine in attenuating hemodynamic responses during laryngoscopy and endotracheal intubation.

AIM

To compare the efficacy of two different doses of intravenous Dexmedetomidine on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation inpatients undergoing general anaesthesia.

Objective

  1. To compare the efficacy in attenuating heart rate during laryngoscopy and endotracheal intubation.

  2. To compare the efficacy in attenuating blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) during laryngoscopy and endotracheal intubation.

  3. To compare post operative sedation between the study groups by RAMSAY Sedation Score.

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 Anesthesiologists (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 Body Mass Index more than 30 kg/m2 .

Patients with history of muscular disorder myositis or any local infection

Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking betablockers.

Patients with cerebrovascular, hepatic and renal diseases.

Psychiatric patients.

Patients with history of allergy to an α-2 adrenergic agonist

Pregnancy & lactating women.

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 A and Group B of 15 patients each:

Group A: patients will receive Inj. Dexmedetomidine 1mcg/kg intravenously as an infusion in 100ml Normal Saline 30 minutes prior to induction of general anaesthesia.

Group B: patients will receive Inj. Dexmedetomidine 1.5mcg/kg intravenously as an infusion in 100ml Normal Saline 30 minutes prior to 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 at baseline, every 15 mins after intravenous injection of test drug till induction, after giving inducing agents, during laryngoscopy and intubation and at 1,3,5 & 7 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 Observational 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; chii“square test will be used. p value <0.05 will be considered statistically significant.

Likely outcome/ Benefit of the study:

This prospective and observational 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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to sign informed consent Male or female patients between 18 to 60 years of age Patients belonging to American Society of Anesthesiologists physical status I and II Patients posted for elective surgeries under general anaesthesia.

排除标准

  • Patients unwilling to participate in the study Patients with Body Mass Index more than 30 kg/m2 Patients with history of muscular disorder myositis or any local infection Patients with cardiovascular diseases arrhythmias heart blocks or taking beta blockers Patients with cerebrovascular, hepatic and renal diseases.
  • Psychiatric patients.
  • Patients with history of allergy to an α-2 adrenergic agonist Pregnancy & lactating women.

结局指标

主要结局

to check efficacy of dexmedetomidine for blunting hemodynamic resonse during laryngoscopy and intubation via intravenous route in two different doses

时间窗: baseline | every 15 minutes after administrating drug | at induction | at laryngoscopy | at 3 mins | at 5 mins | at 7 mins

次要结局

  • to study sedation status post operatively(post operatively sedation status will be assessed every 30 minutes for 3 hours by RAMSAY sedation score)

研究者

发起方
Smt. Bhikiben 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

Harsh Chandreshbhai Rathod

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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