A prospective comparative study of effects of intravenous dexmedetomidine versus intravenous magnesium sulfate in attenuating hemodynamic stress responses during laryngoscopy and endotracheal intubation in spine surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- This prospective and observational study will help us to compare the efficacy of intravenous Dexmedetomidine versus intravenous Magnesium sulphate for attenuation of the pressor response to larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal intubation.
研究概览
简要总结
A PROSPECTIVE COMPARATIVE STUDY OF EFFECTS OF INTRAVENOUS DEXMEDETOMIDINE VERSUS INTRAVENOUS MAGNESIUM SULFATE IN ATTENUATING HEMODYNAMIC STRESS RESPONSES DURING LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN SPINE SURGERIES
**Objective:**To compare the efficacy of intravenous Dexmedetomidine versus Magnesium sulfate in attenuating heart rate during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anasethesia.
To compare the efficacy of intravenous Dexmedetomidine versus Magnesium sulfate in attenuating blood pressure during
laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anasethesia.
INCLUSION CRITERIA
Patients willing to sign written & informed consent.
Male or female patients between ages of 18 to 60 years.
Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
Patients posted for elective spine surgeries under general anesthesia
EXCLUSION CRITERIA
Patients unwilling to participate in the study.
Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.
Patients having arrhythmias or heart block.
Psychiatric patients.
Pregnancy & lactating women.
Patients taking beta blockers.
History of allergy to the study drugs.
Anticipated difficult airway.
BMI greater than 30
Patient having Neuromuscular disease
Serum magnesium level greater than 2.5mEq per L
Site of Study: Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat**.**
Study Design- Prospective comperative study
Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or 18 months whichever is earlier.
Data will be collected & tabulated. 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
This prospective and observational study will help us to compare the efficacy of intravenous
Dexmedetomidine versus intravenous Magnesium sulphate for attenuation of the pressor response to
larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most
beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal
intubation.
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 written & informed consent.
- •Male or female patients between ages of 18 to 60 years.
- •Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
- •Patients posted for elective spine surgeries under general anesthesia.
排除标准
- •Patients unwilling to participate in the study.
- •Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.
- •Patients having arrhythmias or heart block.
- •Psychiatric patients.
- •Pregnancy & lactating women.
- •Patients taking beta blockers.
- •History of allergy to the study drugs.
- •Anticipated difficult airway.
- •BMI greater than 30 Patient having Neuromuscular disease Serum magnesium level greater than 2.5mEq per L.
结局指标
主要结局
This prospective and observational study will help us to compare the efficacy of intravenous Dexmedetomidine versus intravenous Magnesium sulphate for attenuation of the pressor response to larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal intubation.
时间窗: Monitoring of parameters i.e. HR, SBP, DBP, MAP, SPO2 will be noted at baseline, after administration of test drug, after induction, during laryngoscopy and intubation and at 1,3,5 minutes after intubation.
次要结局
- To study sedation score after extubation or any(side effects.)
研究者
Dr Karnati Eshwar
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
