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临床试验/CTRI/2024/01/061788
CTRI/2024/01/061788招募中不适用

To assess the correlation between multiple glycemic parameters in perioperative period with post operative outcome in patients undergoing elective craniotomy or craniectomy for tumor resection- A prospective observational study.

Christian Medical College1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
1
主要终点
To assess the correlation between multiple glycemic parameters - Glycosylated Haemoglobin (HbA1c), glycemic gap (GG), stress hyperglycemia ratio (SHG) and Glycemic Stress Index (GSI) in the perioperative period with duration of ICU stay in patients undergoing elective craniotomy

研究概览

简要总结

Perioperative hyperglycemia is associated with higher risk of perioperative complications, worsened neurologic outcomes, shorter survival and increased mortality in patients undergoing craniotomy and tumor resection. It has been shown that even mild hyperglycemia in the perioperative period  is associated with poorer outcomes. However, whether this is due to pre-existing diabetes mellitus or stress induced hyperglycemia has not been studied.

It is well established that perioperative hyperglycemia is common both in diabetic and non-diabetic patients undergoing craniotomy for tumor resection. Although the underlying mechanisms of perioperative hyperglycemia in the neurosurgical patients are poorly understood, several factors such as the use of corticosteroids and the stress response to brain surgery are believed to play an important contributing role.

Craniotomy is associated with multiple steps with significant stress response such as induction of anaesthesia, intubation, skull pin placement, skin incision, craniotomy, dural incision and extubation.

In the neurosurgical patient, the stress response due to autonomic, hormonal and metabolic changes induced by surgery and anaesthesia are dependent both on the extent and duration of the procedure and is not the same for each patient.

However, there is not enough literature focusing on distinguishing between Stress induced hyperglycemia (SHG) and diabetic mellitus (DM) among this population and its effect on perioperative outcomes. Glycosylated haemoglobin (HbA1C) which is commonly used to assess pre-operative glycemic status is an estimate of chronic glycemic control and it is not affected by acute illness. Recently, we have multiple glycemic parameters to assess stress induced hyperglycemia such as glycemic gap (GG), stress hyperglycemia ratio (SHR) and Glycemic Stress Index (GSI). These measure the glycemic variability which reflects the magnitude of glycemic excursions, which are in-turn are affected by the stress of surgery and are known to be associated with poor outcomes in critical illness.

In our study, we would like to study the correlation between multiple glycemic parameters which are reflectors of stress induced hyperglycemia with post-operative and intra operative outcomes in patients undergoing elective craniotomy.

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
All

入选标准

  • Patient posted for elective craniotomy or craniectomy for brain tumor resection.

排除标准

  • GCS less than 15 Patients refusal Patients on other steroids other than Dexamethasone Recent Hospitalisation Renal impairment.

结局指标

主要结局

To assess the correlation between multiple glycemic parameters - Glycosylated Haemoglobin (HbA1c), glycemic gap (GG), stress hyperglycemia ratio (SHG) and Glycemic Stress Index (GSI) in the perioperative period with duration of ICU stay in patients undergoing elective craniotomy

时间窗: Preoperative period, Intraoperative period, post operative period

次要结局

  • Perioperative Noradrenaline Requirement(Till ICU stay)
  • Lactate values(Pre and Post surgery)
  • intraoperative hypoglycemia and hyperglycemia episodes(hypoglycemia 80mg per ml)
  • Postoperative hypo and hyperglycemias(Hypoglycemia 80mg per ml)
  • Duration of post operative mechanical ventilation(Mechanical ventilation in hours)
  • Length of Hospital stay(In Days)
  • ICU Readmision(Yes or No)
  • Post operative infection(Yes or No)
  • Reoperation(Yes or No)
  • Postoperative Neurological outcome assessed by Modified Rankin Score and Karnofskys performance score(modified rankin score 0 to 5)
  • Quality of Life as assessed by QoR 15 Questionnaire(30 day QoR 15 questionnaire)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nandi Vinayaka B

Christian Medical College

研究点 (1)

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