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临床试验/CTRI/2026/03/106064
CTRI/2026/03/106064尚未招募不适用

Opioid free anaesthesia with Pecs and Pecto-Intercostal fascial plane blocks versus opioid based general anaesthesia in breast cancer surgeries

Dr Atul C Thankachen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月23日最近更新:

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

研究概览

简要总结

Breast cancer surgeries are generally done using strong opioids. However, these drugs carry disadvantages such as postoperative nausea and vomiting, respiratory depression, suppression of immune and gastrointestinal function, which hinder rapid recovery of patients in the early postoperative period. Our objective is to study the immediate patient outcomes using opioid free anaesthesia (OFA) with block and Dexmedetomidine, Ketamine and Magnesium vs conventional opioid based anaesthesia (OBA). OFA group will receive premedication with dexmedetomidine 0.5 mg/kg and MgSO4 20 mg/kg in 100 ml NS over 10 mins intravenously. After induction patients will be given infusion of dexmedetomidine (1 mcg/ml) with ketamine (1 mg/ml) at 1 ml/10 kg/hr. They will also receive PECS-Pectointercostal Fascial Plane block before the start of surgery. Conventional OBA group will receive fentanyl at 2 mcg/kg during induction. Both groups will be induced General Anaesthesia with propofol and vecuronium. Anaesthesia will be maintened with sevoflurane at MAC of 0.8-1.2 in oxygen air mixture. Intra operatively paracetamol and dexamethasone will be given and at the end of surgery reversal will be done with neostigmine and glycopyrrolate.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Patients scheduled for elective breast surgeries including Breast-Conserving Surgery and Sentinel Lymph Node Biopsy, Simple mastectomy, Modified radical mastectomy.
  • American Society of Anaesthesiologists (ASA) grade I or II.

排除标准

  • Patients with severe cardiovascular and cerebrovascular disorders.
  • Significant hepatic and renal dysfunction.
  • Allergy to local anaesthetics or opioids.
  • Infection at puncture site.
  • Coagulation disorders.
  • Patients undergoing bilateral breast surgeries.
  • Refusal to participate by the patient or family members.

研究者

发起方
Dr Atul C Thankachen
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Atul C Thankachen

Government medical college, Kottayam

研究点 (1)

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