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临床试验/CTRI/2024/07/070845
CTRI/2024/07/070845尚未招募4 期

A randomized comparative study of postoperative analgesic requirement in robot assisted versus laparoscopic urology study

Sawai Man Singh Medical College and attached hospitals Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1 To assess and compare analgesic requirement in first 24 hours in both study groups

研究概览

简要总结

The shift from open to minimally invasive urology surgery, driven by advancement in imaging, endoscopic technology offer benefits like early ambulation, quicker recovery, reduced cost of hospital stay, reduced analgesic requirements. The postsurgical pain and the morbidity patients undergo is more frequently due to traumatic injury while gaining access to intended site of surgery rather than surgery itself.

Inadequate analgesia may lead to postoperative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay and increased mortality. Moreover, acute postoperative pain is associated with an increased risk of chronic pain.Therefore optimal analgesic treatment is essential for improving the quality of pain management after surgeries.

Robots improve field visibility with greater depth perception, fine movement control, and enable more ergonomic anatomic movements of instruments closely mimicking human wrist movements. While the technical ease of resection and

surgeon’s instrumentation freedom are discussed in detail in many studies.

There is limited studies on anesthetic implications, analgesic requirements and benefits of robot assisted surgery over laparoscopic surgeries.

Hence, we designed this study to compare postoperative analgesic requirement between robot assisted versus laparoscopic urology surgery in the first 24hrs after surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patient consenting to participate belonging to American Society of Anesthesiologist (ASA) I.
  • III aged 18-75 years undergoing elective robotic or conventional laparoscopic urology surgery.

排除标准

  • Patients not consenting to participate Severe coronary artery disease Severe valvular heart disease Allergy to paracetamol tramadol fentanyl History of excessive alcohol or drug abuse Patients who are part of other study.

结局指标

主要结局

1 To assess and compare analgesic requirement in first 24 hours in both study groups

时间窗: 1 To assess and compare analgesic requirement in first 24 hours in both study groups | 2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours

2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours

时间窗: 1 To assess and compare analgesic requirement in first 24 hours in both study groups | 2 To assess and compare Mean NRS score between study groups at 0-1-2-4-6-12-24 hours

次要结局

  • 1 To assess & compare various hemodynamic parameters(heart rate, systolic blood pressure, diastolic blood pressure, spO2) at various interval in both groups(2 To assess & compare time to ambulation)

研究者

发起方
Sawai Man Singh Medical College and attached hospitals Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Varsha kothari

SMS Medical College

研究点 (1)

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