跳至主要内容
临床试验/CTRI/2025/08/093867
CTRI/2025/08/093867尚未招募不适用

Impact of preoperative dexamethasone versus placebo on quality of recovery in patients undergoing surgery for gastrointestinal and hepato-pancreato-biliary malignancy- Randomized controlled trial

Aiims Rishikesh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To evaluate the impact of preoperative dexamethasone on quality of recovery in patients undergoing surgery for GI and HPB malignancy (using QOR-40 score)

研究概览

简要总结

Postoperative systemic inflammatory-immune dysregulation is a key component of the body’s response to surgical injury, increasing the risk of complications and leading to extended hospital stays. Perioperative glucocorticoid can suppress this response, thereby reducing complication and enhancing post-operative recovery

One of the primary mechanisms of glucocorticoids is their ability to suppress inflammation. They inhibit the transcription of key pro-inflammatory transcription factors such as AP-1, NF-kB, and STAT3, which leads to a reduction in the production of pro-inflammatory cytokines.However, the use of glucocorticoid in improving the post operative quality of recovery among patients of gastrointestinal malignancy (GI) and hepato pancreto-biliary(HPB) malignancy is limited.

Numerous article report safety of glucocorticoids and their use for postoperative nausea, vomiting and pain. Most studies report that their use reduces the post operative complication without increasing blood sugar level and risk of surgical site infection. However no study directly examine the effect of preoperative dexamethasone on improving quality of recovery in patient of GI and HPB malignancy after curative surgery.

Therefore, aim of the study is to assess the impact of preoperative dexamethasone versus placebo on quality of recovery in patients undergoing surgery for gastrointestinal(GI) and hepato-pancreato-biliary (HPB) malignancy

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients undergoing curative intent elective surgery for gastrointestinal malignancy • ECOG 0-2 • Written, informed consent.

排除标准

  • 未提供

结局指标

主要结局

To evaluate the impact of preoperative dexamethasone on quality of recovery in patients undergoing surgery for GI and HPB malignancy (using QOR-40 score)

时间窗: post operative day 3 | post operative day 5

次要结局

  • length of Intensive care Unit stay
  • 30 day morbidity(30 days)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shubham Agarwal

AIIMS Rishikesh

研究点 (1)

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