Comparison of recovery profile between target controlled infusion of propofol & sevoflurane anaesthesia in patients undergoing retrograde intrarenal surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recovery time and extubation time assessment
研究概览
简要总结
Rapid recovery is a highly desirable objective of anaesthesia. Extended recovery time from general anaesthesia may lead to severe complications like hypoxemia, hypercarbia, hypoventilation, etc. Recovery time is influenced by patient factors, anaesthetic agents used, and surgical factors.
Inhalational anaesthesia is the most popular form of anaesthesia used since it is easy to administer and can be rapidly titrated. But these anaesthetic gases used pose a threat as they are potent greenhouse gases that can contaminate the air and contribute to the greenhouse effect. The sole modality that completely eliminates the use of anaesthetic gases is total intravenous anaesthesia (TIVA).
The increased popularity of TIVA can be attributed to pharmacokinetics and pharmacodynamics of short acting drugs like propofol and remifentanil. Propofol can be administered through target controlled infusion (TCI) with precise concentration using Marsh or Schnider pharmacokinetic models. TCI involves automated intravenous drug administration that regulates drug delivery rates to achieve desired target plasma concentration (Cp) or at effect site concentration (Ce). TCI offers several advantages over conventional inhalational anaesthesia, including better post operative recovery, stable hemodynamics, a reduced rate of post-operative nausea and vomiting.
Hence, the current study is designed to compare two standard techniques of anaesthesia, that is, ‘TIVA via TCI’ and ‘inhalational anaesthesia’, while maintaining bispectral index (BIS) value between 40-60, in patients undergoing retrograde intrarenal surgery (RIRS).
This study is a randomised controlled trial with a sample size of 100 and will be conducted in MS Ramaiah Medical College, Bangalore. The primary outcome will be to compare recovery time and extubation time in the two groups. The secondary outcome will be to compare hemodynamic profile, Modified observer’s assessment of alertness/sedation scale score and discharge time in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 20-65 years Patients undergoing elective retrograde intrarenal surgery (RIRS).
排除标准
- •Patients with severe cardiovascular, renal, hepatic disorder Patients with neuropsychiatric disorders Patients with hemodynamic instability Patients with drug allergy Patients with history of malignant hyperthermia Patients with muscular dystrophy Patients with electrolyte imbalance Conversion of procedure to Percutaneous nephrolithotripsy(PCNL).
结局指标
主要结局
Recovery time and extubation time assessment
时间窗: Recovery time is the interval from cessation of anaesthetic agents to eye opening in response to verbal command. | Extubation time is the time interval from the end of surgery to removal of endotracheal tube
次要结局
- Hemodynamic profile, Modified observers assessment of alertness/sedation scale score, discharge time assessment(Hemodynamic profile will be noted pre-anaesthesia, pre induction, when BIS value reaches 40-60, at intubation, & at 10 minute intervals till extubation.)