comparison of effect of opioid free anaesthesia versus opioid based anaesthesia on post operative recovery profile and consumption of sevoflurane in patients undergoing laparoscopic surgeries: a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dosage of sevoflurane consumed intraoperatively.
研究概览
简要总结
| The intraoperative administration of opioids was considered as a foundation of anaesthesia. It is used to stabilize the hemodynamics during anaesthesia. Opioids are met with adverse effects, such as respiratory depression, nausea/ vomiting, constipation, tolerance and hyperalgesia. This in turn results in delayed recovery and prolonged hospital stay. |
Opioid-free anesthesia (OFA) have been introduced in order to overcome these adverse effects. In OFA, both central and peripheral pathways, are blocked by drugs acting on sodium channels, G-protein-coupled receptors, and N-methyl-D-aspartic acid (NMDA) receptors, some of which also have anti-inflammatory activity.
Inhalational anaesthetics contributes significantly to healthcare-related greenhouse gas emissions, ozone depletion. Prolonged exposure to inhalational agents have shown risks of health hazards, potential to cause genetic damage and oxidative stress among health care personnel in working environments with poor or inadequate scavenging of inhaled anaesthetics. Anaesthetic drugs account for upto 6% of total pharmacy costs, out of which inhalational agents contributes upto 20%.Monitoring depth of anaesthesia partly helps to deliver appropriate dose of anaesthetic agents and helps to overcome these burdens. One such measure is patient state index (PSI) which measures the effect of anaesthesia and level of consciousness.
Our study aims to compare the effect of opioid based anaesthesia over opioid free anaesthesia in intraoperative awareness, post operative recovery profile, consumption of inhalational agents so as to facilitate early discharge of the patient, cut down the cost of anaesthesia as well as the environmental pollution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 who are willing to give informed consent.
- •Patients of age 18 to 60 years.
- •ASA grades 1 and
- •Patients with BMI 19 to 25 Patients undergoing laparoscopic surgeries Duration of surgery 90 minutes.
排除标准
- •Patient refusal.
- •Patients with history of allergy to egg, soya, opioids.
- •Patients with severe systemic diseases.
- •Patient requiring postoperative mechanical ventilation.
- •Patients with neurologic or psychiatric illness.
- •Patients with past history of cardiovascular diseases.
结局指标
主要结局
Dosage of sevoflurane consumed intraoperatively.
时间窗: PSI values and end tidal sevoflurane concentration will be monitored every 5 minutes for the first 30 minutes followed by every 10 minutes for the next one hour.
次要结局
- various scoring systems like vas score, apfel score, modified aldrete score for recovery profile.(various scoring systems like vas score, apfel score, modified aldrete score will be monitored in immediate post operative period and then at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours post operatively.)
研究者
Dr E M Chandni
Bangalore medical college and research institute