A STUDY TO COMPARE THE EFFICACY BETWEEN TOTAL INTRAVENOUS ANAESTHESIA WITH PROPOFOL AND BALANCED ANAESTHESIA WITH SEVOFLURANE IN TERMS OF RECOVERY PROFILE AND HEMODYNAMIC CHANGES DURING LARAROSCOPIC CHOLECYSTECTOMY- A RANDOMISED CONTROLLED STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To compare post-operative recovery profile between patients receiving propofol versus sevoflurane following laparoscopic cholecystectomy
研究概览
简要总结
Study Title
A randomized controlled study to compare the efficacy of Total Intravenous Anaesthesia TIVA using Propofol versus Balanced Anaesthesia using Sevoflurane on recovery profiles and hemodynamic stability in patients undergoing laparoscopic cholecystectomy
Background and Justification
Laparoscopic cholecystectomy is a common minimally invasive procedure yet it presents unique physiological challenges including hemodynamic fluctuations due to pneumoperitoneum and a high incidence of postoperative nausea and vomiting PONV While Sevoflurane is a standard inhalational agent known for its titratability Propofol based TIVA is theorized to offer superior hemodynamic stability and a smoother clearheaded recovery with reduced PONV This study aims to provide evidence on which technique optimizes patient outcomes in the perioperative period
Objectives
Primary To compare the recovery profile emergence time extubation time and cognitive recovery between the TIVA and Sevoflurane groups
Secondary To evaluate and compare hemodynamic changes Heart Rate Mean Arterial Pressure at key intervals induction intubation pneumoperitoneum and extubation
Tertiary To assess the incidence of postoperative side effects specifically PONV and shivering
Methodology
Study Design Prospective Randomized Controlled Trial RCT
Participants Adults eg ASA physical status I and II scheduled for elective laparoscopic cholecystectomy
Intervention Group A Total Intravenous Anaesthesia TIVA using Propofol infusion
Comparator Group B Balanced General Anaesthesia using Sevoflurane with an oxygen nitrous oxide or air mix
Standardization Both groups will receive standardized premedication analgesia eg Fentanyl and neuromuscular blockade
Expected Outcome
The study seeks to determine if Propofol based TIVA provides a more stable hemodynamic course during the stress of CO2 insufflation and results in a faster more comfortable recovery compared to Sevoflurane based inhalation anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
- •Patients belonging to ASA Grade I, II, Patients aged between 20 and 50 years of either sex, Patient willing to give informed consent.
排除标准
- •Patient refusal Heavy smoker (more than 20 cigarettes per day), patients having hemorrhagic disorders or patients with anticoagulant therapy, other systemic disorders, Patients on MAO-inhibitors, antidepressants and b-blockers, Patient had general anesthesia within the past 2 weeks Patients with history of allergy or sensitivity to volatile anesthetics or to propofol Patients with body mass index more than 1.5 times normal.
结局指标
主要结局
To compare post-operative recovery profile between patients receiving propofol versus sevoflurane following laparoscopic cholecystectomy
时间窗: After Extubation 0 mins | Eye opening time 5-10 mins | Time for following verbal commands5-10 mins | Time for speaking name by patient5-10 mins | Time to achieve modified Aldrete score5-10 mins
次要结局
- To compare the intra operative hemodynamic parameters, between propofol versus sevoflurane in patients undergoing laparoscopic cholecystectomy.(intraop)
研究者
CHANDANA N P
Bangalore Medical College and Research Institute