A randomized control study on effects of Dexmedetomidine, Magnesium sulphate and Propofol in middle ear surgeries
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 compare the efficacy of intraoperative use of Propofol, Dexmedetomidine and Magnesium sulphate for controlled hypotension (MAP of 55-65 mmHg) in middle ear surgeries
研究概览
简要总结
This is a randomized control study and aims to compare the effects of Propofol , Dexmedetomidine and Magnesium sulphate in middle ear surgeries .Primary objectives of the study is to compare the efficacy of intraoperative use of Propofol , Dexmedetomidine and Magnesium sulphate for controlled hypotension (MAP of 55-65 mmHg) in middle ear surgeries. The secondary objective is to assess oligemic field during the surgery , to compare the anaesthetic agent consumption (oxygen, air and isoflurane) at the end of the surgery , to compare the degree of postoperative pain and postoperative nausea and vomiting.The recruited patients will be randomized and allocated into one of the three groups-Group P(Propofol),Group M(Magnesium sulphate) and Group D(Dexmedetomidine) by a computer generated table.The study drugs will be given as a boluses over 15 minutes(Propofol 6mg/kg/hr, Dexmedetomidine 1mcg/kg in 100mL NS, Magnesium sulphate 30mg/kg in 100 mL NS) before the time of incision, followed by and infusion( Propofol 4mg/kg,Dexmedetomidine 0.3mcg/kg/hr,Magnesium sulphate 10mg/kg/hr) till the microscope used for surgery is taken off.
The outcome variables and their measures:
1)Intraoperative haemodynamics at 5,10,15,20,30,45,60,78,90,105 and 120 minutes respectively
2)Oligemic field as assessed by the surgeon at the end of the surgery
- Anaesthetic agent consumption at the end of the surgery
4)Post operative nausea and vomiting, Post operative pain – Early ( 5 minutes, 30 minutes, 1 hour ) and late ( 2 hours and 8 hours)
Descriptive and inferential statistical analysis will be done .Results on continuous measurements are presented as Mean +/- SD.Results on categorical measurements are presented as number %.Analysis of variance (ANOVA) will be used to find the significance of study parameters between three groups of patients. Student t test will be used to find the significance of study parameters within each group.Chi square/ Fisher exact test will be used to find the significance of study parameters on categorical scale between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18-59 years posted for middle ear surgeries.
- •ASA 1 and 2 patients with well controlled co-morbidities.
排除标准
- •Patients already on chronic analgesic medications 2)Obese patients BMI>30 3)Pregnant patients 4)Patients with h/o motion sickness,reflux and previous h/o post operative nausea , vomitting.
结局指标
主要结局
To compare the efficacy of intraoperative use of Propofol, Dexmedetomidine and Magnesium sulphate for controlled hypotension (MAP of 55-65 mmHg) in middle ear surgeries
时间窗: At 5,10,15,20,30,45,60,78,90,105 and 120 minutes
次要结局
- To assess oligemic field during the surgery.(To compare the anaesthetic agent consumption (Oxygen, Air and Isoflurane ) at the end of the surgery.)
