Comparsion of effects of adjuvants fentanyl and dexmedetomidine with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries: a randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To determine the onset and duration of sensory and motor block of intrathecal hyperbaric levobupivacaine alone, hyperbaric levobupivacaine with fentanyl, and hyperbaric levobupivacaine with dexmedetomidine
研究概览
简要总结
The study will be prospective, randomised and double blinded. We will compare the effect of fentanyl vs dexmeditomedine as adjuvants to hyperbaric levobupivacaine on patients undergoing infraumbilical surgery under spinal anaesthesia. It is aimed to compare the onset and duration of sensory and motor block , hemodynamic changes, duration of analgesia, need of rescue analgesia and post-operative analgesic profile. A total number of 93 patients who fall under ASA category I and II will be recruited. They will be randomly allocated into 3 groups containing 32 each designated as Group A, B, C. Group A constitutes patients receiving 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml (10mcg) of fentanyl. Group B patients will receive 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml (0.5mcg) of dexmeditomedine (0.5ml=50mcg, diluted to 2ml by addition of 1.5ml NS so that each 0.1ml contains 2.5 mcg of dexmeditomedine). Group C 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml of Normal Saline. Patients will be assessed for the impact of drugs on the parameter mentioned above and the data will be recorded. The data will be then analysed and interpreted by appropriate statistical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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 aged between
- •60 years undergoing infraumbilical surgeries
- •Patients who are categorised under ASA I and II
- •Patients who have signed a written informed consent form.
排除标准
- •Patients refusal
- •Pregnant women
- •Patients with spine deformities, local infection near the injection site
- •Patients with history of allergy to study drugs
- •Patients with abnormal coagulation profile.
结局指标
主要结局
To determine the onset and duration of sensory and motor block of intrathecal hyperbaric levobupivacaine alone, hyperbaric levobupivacaine with fentanyl, and hyperbaric levobupivacaine with dexmedetomidine
时间窗: The level of sensory block will be assessed by pin prick method every minute after drug administration till 15 minutes from start, then every 15 minutes till the completion of surgery. | Motor block will be assessed by Modified Bromage Scale every minute till Modified Bromage grade 3 is achieved. | Then motor block assessed every hourly for 3 hours
次要结局
- Hemodynamic effects. Heart rate, blood pressure, oxygen saturation(baseline, then every 5 minutes after administration of drug till the surgery ends)
- Total number of rescue analgesia required(till 12 hours after completion of surgery)
- Analgesic profile(1. Visual Analog Scale at the end of surgery)