A comparative study to evaluate the efficacy of intrathecal clonidine versus clonidine with fentanyl in patients undergoing laparoscopic surgeries under conventional general anaesthesia.
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
- Haemodynamic variables
研究概览
简要总结
This is a prospective randomized double blind study comparing the efficacy of intrathecal clonidine 150 micrograms versus intrathecal clonidine 75 micrograms with intrathecal fentanyl 25 micrograms in patients undergoing elective laparoscopic surgeries of duration less than 2 hours under conventional general anaesthesia. iI will be conducted in a total of 60 patients, 30 in each group, in alll the hospitals attached to Bangalore Medical College and Research Institute.The primary outcome is to compare the intraoperative haemodynamic variables along with the haemodynamic response to intubation and extubation. Duration of post operative analgesia and sedation status will also be observed in the post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give informed written consent.
- •ASA physical status I and II patients.
- •Patients of age group 18-55 years, of either sex.
- •Patients undergoing elective laparoscopic surgeries under general anaesthesia lasting less than 2 hours.
- •Patients with Body Mass Index between 18 to 30 kilograms per metre square.
排除标准
- •Patients with contraindications to spinal technique.
- •Patients with known allergy to clonidine and fentanyl.
结局指标
主要结局
Haemodynamic variables
时间窗: Intraoperative period - every five minutes till 30 minutes followed by every ten minutes till 60 minutes followed by every fifteen minutes till the end of the surgery
次要结局
- Haemodynamic response to intubation and extubation(After one minute and five minutes of intubation and after one minute and five minutes of extubation)
- Analgesia(The time required for the patient in the post operative ward for the first rescue analgesic when Visual analogue score is greater than 3)
- Sedation(Five minutes immediately after extubation in the post operative period)
- Incidence of hypotension, hypertension, bradycardia, tachycardia(24 hours in the post operative period)