跳至主要内容
临床试验/CTRI/2025/02/080666
CTRI/2025/02/080666尚未招募不适用

To compare the efficacy and safety of intrathecal Morphine and Fentanyl on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月27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
60
试验地点
1
主要终点
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics

研究概览

简要总结

Hepatobiliary surgeries are more frequently performed nowadays due to a rising incidence of hepatobiliary diseases. Effectively administered analgesia enables greater patient satisfaction by minimising acute postoperative pain, alleviates the acute physiological stress response to surgery, and facilitates enhanced recovery outcomes including early mobilisation and return to normal activity, reduced length of hospital stay, and reduced cardiac, respiratory and gastrointestinal postoperative complications leading to improved long-term patient survival rates. Thoracic epidural analgesia is considered the gold standard analgesic modality for patients undergoing hepatobiliary surgeries as it provides adequate analgesia to support mobilization, with significant reduction in pulmonary, cardiovascular and thromboembolic morbidity in early post-operative period and reduced requirement of additional opioid analgesia. However , there exists high rates of epidural failure and  complications especially since it is an invasive, high-cost, labour-intensive technique. Also , there is increased risk of epidural hematoma formation  due to coagulation abnormalities after hepatobiliary surgeries, even in patients with normal preoperative coagulation profile. Furthermore,  the epidural catheter should be removed in a timely manner to minimize complications due to post-operative coagulation disturbances. In view of the concerns raised with epidural analgesia in hepatobiliary surgeries, intrathecal anaesthesia has emerged as a promising simpler and quicker alternative technique, yielding better patient outcomes with a lower rate of technical failure. Fentanyl is a phenyl piperidine derivative, synthetic opioid agonist which is more potent, more lipid soluble with faster onset of action and relatively shorter duration of action. Morphine is a hydrophilic phenanthrene derivative with comparatively slower onset of action and a significantly longer duration of action. However, it has the potential to cause adverse effects, especially delayed respiratory depression and hence requires more vigilant protocol. Hence this study aims at comparing the efficacy and safety of intrathecal morphine and fentanyl in hepatobiliary surgeries under GA , in terms of intraoperative and post operative analgesia, requirement of rescue analgesics and potential side effects.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients belonging to American Society of Anaesthesiologist class I-II, willing to give informed written consent, scheduled to undergo elective hepatobiliary surgeries under general anaesthesia.

排除标准

  • Patients not willing to give consent Patients undergoing emergency surgeries Patients having allergy to study drugs Patients having spinal anomalies or infection, coagulopathy, increased intracranial pressure Patients belonging to American Society of Anaesthesiologists class III-V Expected duration of surgery less than 90 min.

结局指标

主要结局

To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics

时间窗: To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics at 2nd, 4th, 8th, 12th and 24th hour following surgery.

次要结局

  • To assess post-operative analgesia using VAS score(To assess the VAS score at 2,4,8,12 and 24 hours post-operatively)
  • To compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough, respiratory depression and sedation(To assess the incidence of side effects and their)

研究者

发起方
Bangalore Medical College and Research Institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sandhya K

Bangalore Medical College and Research Institute

研究点 (1)

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