CTRI/2020/02/023181尚未招募不适用
Comparison between fentanyl and butorphanol as epidural adjuvants in combined spinal epidural anaesthesia for lower limb surgeries - A prospective randomized study
Sangeetha G G1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年10月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To determine the quality and duration of analgesia postoperatively using Visual analogue scale and time of requirement of rescue analgesia respectively
研究概览
简要总结
This is a randomized controlled trial to compare the efficacy of Fentanyl and Butorphanol as adjuvants to combined spinal epidural anaesthesia among 46 patients posted for lower limb surgeries over a period of 18 months. The primary objective is to determine the quality and duration of analgesia post-operatively. The secondary outcomes are to assess sedation score and incidence of adverse effects such as pruritis, nausea, vomiting, shivering, hemodynamic instability.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective lower limb surgeries under combined spinal and epidural anaesthesia American Society of Anaesthesiologist I or II.
排除标准
- •Patient refusal Patients allergic to local anesthetics/Butorphanol/Fentanyl American Society of Anaesthesiologist III and above Patients with coagulation disorders Local site infection BMI above 30 Poorly controlled Hypertension Poorly controlled Diabetes mellitus Patients with cardiac pathology Pregnant patients.
结局指标
主要结局
To determine the quality and duration of analgesia postoperatively using Visual analogue scale and time of requirement of rescue analgesia respectively
时间窗: Postoperative Period
次要结局
- To assess sedation score and adverse effects such as pruritis, nausea and vomiting, shivering, hemodynamic stability up to 24 hours postoperatively between the two groups(Postoperative Period)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A study for the comperison of pain-free duration after administration of inj.butorphenal vs inj.fentanyl with inj.levobupivacaine epidurally in patients undergoing vaginal hysterectomyCTRI/2023/12/060886JLN medical college80
招募中
不适用
COMPARISION OF ADDITION OF FENTANYL V/S NEOSTIGMINE TO BUPIVACAINE IN UPPER LIMB SURGERIES FOR DURATION OF ANALGESIACTRI/2021/01/030277NOT APPLICABLE60
尚未招募
3 期
A clinical trial to study the effects of two drugs, Fentanyl and Butorphanol in combination with another drug Propofol for general anaesthesia using a device called Laryngeal mask airway.CTRI/2013/08/00388140
尚未招募
不适用
A prospective study to compare efficacy of fentanyl versus buprenorphine as an adjuvant to local anaesthetic hyperbaric bupivacaine given in spinal anaesthesia in orthopaedic surgeriesCTRI/2023/03/051128Kallepally Sannidhi100
尚未招募
4 期
Effects of fentanyl and dexmedetomidine as adjuvants with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeriesCTRI/2025/06/089299Jawaharlal Nehru Institute of Medical Sciences, Imphal96