Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- total intravenous anesthesia
研究概览
简要总结
Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small duration cases. But in recent times, concept of rapid discharge, day care procedures, and green environment has created the need of new modalities of anaesthesia for such cases. Considering such factor, investigators have planned using TIVA i.e. total intravenous anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is feasible, cost effective and comparable to inhalational anaesthesia in terms of intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile. This comparison and analysis will help to determine if TIVA can be used as the sole mode of anaesthesia during MRM as it will initiate early discharge of patient and will contribute to the Green OT concept.
详细描述
Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified Radical Mastectomy
Objective:
- Feasibility of TIVA in Modified Radical Mastectomy
- Cost - effectiveness of TIVA Vs Inhalational anesthesia
- Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing intraoperative hemodynamic parameters and recovery profile.
Study design: It will be a prospective randomized controlled interventional type of study.
Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T) and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
participants will be alloted in two groups as per chit system and won't be aware of type of anaesthesia, investigator won't be aware of type of anaesthesia and will record the data.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group: 30-65 yrs
- •ASA status: 1-3
- •Use of endotracheal tube for securing the airway
排除标准
- •CKD, CLD patients
- •Cardiac dysfunction
- •Psychotic and neurotic disorders
- •Drug addiction
- •BMI > 30
- •Use of supraglottic device
- •Use of any nerve blocks
研究组 & 干预措施
Inhalational anaesthesia
In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
干预措施: nitrous oxide (Other)
TIVA - total intravenous anaesthesia
only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
干预措施: Injection dexmedetomidine (Drug)
TIVA - total intravenous anaesthesia
only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
干预措施: Injection, Propofol, 10 Mg (Drug)
Inhalational anaesthesia
In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
干预措施: sevoflurane (Other)
结局指标
主要结局
total intravenous anesthesia
时间窗: 3 hours
Intraoperative Bispectral index maintenance between 40-60
次要结局
- Cost - effectiveness(3 hours)
研究者
Dr. Nitesh Goel
Dr. Nitesh Goel - Consultant Anaesthesia
Rajiv Gandhi Cancer Institute & Research Center, India