a prospective study to compare the efficacy of intravenous versus intramuscular dexmedetomidine in attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To check efficacy of dexmedetomidine for blunting hemodynamic response during laryngoscopy and intubation in two different routes via intramuscular route and intravenous route
研究概览
简要总结
A prospective study to compare the efficacy of intravenous versus intramuscular dexmedetomidine in attenuation of hemodynamic responses during laryngoscopy and endotracheal intubation.
Aim:
To compare the efficacy of intravenous versus intramuscular Dexmedetomidine on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing general anaesthesia.
Objective:
To compare the efficacy in attenuating heart rate during laryngoscopy and endotracheal intubation.
To compare the efficacy in attenuating blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) during laryngoscopy and endotracheal intubation.
To compare post operative sedation between the study groups by RAMSAY Sedation Score.
Group A: patients will receive inj. Dexmedetomidine 1.5mcg/kg intramuscularly 60 minutes prior to induction of anesthesia.
Group Bpatients will receive inj. Dexmedetomidine 1.5mcg/kg intravenously as an infusion in 100ml NS over 20 mins 30 minutes prior to induction of anaesthesia
Drug 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 i.m injection of test drug till induction, after giving inducing agents, during laryngoscopy and intubation and at 1,3,5 & 7 minutes after intubation.
Post-operatively, sedation status will be assessed half hourly by RAMSAY Sedation Score (RSS) till a score of less than or equal to 3 is achieved.
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 ≥ 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 alpha 2 adrenergic agonist
Pregnancy & lactating women.
SiteofStudy:Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.
**Study Design-**Prospective, Observational and Comparative Study
**Study Duration-**The study will be initiated after obtaining the permission from institutional ethics committee for duration of 10 months.
Statistical analysis:
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 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/ Benefits of the study:
This prospective and observational study will help us to compare the efficacy between two different doses of intramuscular Dexmedetomidine in attenuating hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia 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 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.
- •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.
排除标准
- •Patients unwilling to participate in the study.
- •Patients with Body Mass Index ≥ 30 kg/m
- •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 alpha 2 adrenergic agonist Pregnancy & lactating women.
结局指标
主要结局
To check efficacy of dexmedetomidine for blunting hemodynamic response during laryngoscopy and intubation in two different routes via intramuscular route and intravenous route
时间窗: To check efficacy of dexmedetomidine for blunting hemodynamic response during laryngoscopy and intubation in two different routes via intramuscular route and intravenous route at baseline, after detest drug administration, after induction, at laryngoscopy and intubation, 1min, 3 mins, 5mins, 7mins after intubation
次要结局
- To study sedation score or any other side effects(post-operatively sedation status will be assessed every 30 minutes by RAMSAY sedation score till a score of less than or equal to 3 will be achieved.)
研究者
Milloni Shah
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre
