Intravenous Dexmedetomidine (1mcg/kg) versus Intravenous Magnesium Sulphate (50mg/kg)for attenuation of the Hemodynamic Stress Response During Skull Pin Insertion in Patients with Intracranial Neoplasms Undergoing Elective Craniotomy: A Prospective Randomized Comparative Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Measure and compare heart rate between two groups.
研究概览
简要总结
This randomized controlled trial aims to compare efficacy of intravenous dexmedetomidine and intravenous magnesium sulphate in attenuating the hemodynamic response to scalp pin insertion in patients with intracranial neoplasms undergoing elective craniotomy procedures. The study will include patients aged 18 to 60 years with an ASA physical status ii. A total of 60 patients will be randomly allocated in to two groups
Group D: intravenous dexmedetomidine 1 mcg/kg
Group M: intravenous magnesium sulphate 50 mg/kg
Each group consist of 30 patients. Study drugs will be administered according to the assigned group.
Heart rate, systolic, diastolic and mean arterial pressures will be recorded at the following time points,
Pre induction,5 minutes after intubation, before and during pin insertion, 1 minute, 5 minutes, 10 minutes, 20minutes, 30 minutes following pin placement. These measurements will be taken by an anaesthesiologist who is blinded to the patients group allocation and total fentanyl requirement up to 30 minutes will also will be recorded. Magnesium level monitored in all patients pre operatively and after study drug administration
Statistical analysis: data will be entered in to Microsoft excel data sheet and will be analysed using IBM SPSS version 22 software (Armonk, Ny: IBM Corp) software. Normal distribution of data will be assessed with the Kolmogorov Smirnov test. Categorical data will be represented in the form of frequencies and proportions. Chi square test will be the test of significance. Continuous data will be represented as mean and standard deviation. Independent t test will the test of significance to identify the mean proportion between two groups. The Mann Whitney U test will used for the non-normality distributed data. P value <0.05 will be considered as statistically significant.
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 belonging to ASA II aged between 18 to 60 years with intracranial neoplasms undergoing elective craniotomy.
排除标准
- •Patients with known history of allergy to the study drugs.
- •Patients in hypovolemia, heart blocks etc.
- •Patients undergoing emergency surgeries.
- •Patients with more than 20% drop in hemodynamic parameters after study drug administration •Patients with hypermagnesemia.
结局指标
主要结局
1.Measure and compare heart rate between two groups.
时间窗: Before induction, five minutes after intubation, before pin insertion, at the time of pin insertion, one minute, five minutes, 10 minutes, 20 minutes, 30 minutes after pin insertion.
2.Measure and compare systolic blood pressure, diastolic blood pressure and mean arterial pressure between two groups.
时间窗: Before induction, five minutes after intubation, before pin insertion, at the time of pin insertion, one minute, five minutes, 10 minutes, 20 minutes, 30 minutes after pin insertion.
次要结局
- 1.To compare the total fentanyl requirement up to 30 minutes post pin insertion between two groups.(2. Compare the incidence of adverse effects related to study drugs in both groups.)
研究者
Dr Arjun Raveendran
Sri Sathya Sai Institute of Higher Medical Sciences