| CTRI Number |
CTRI/2024/01/061788 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check for stress induced increase in blood glucose in patients undergoing brain surgeries. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandi Vinayaka B |
| Designation |
Senior resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Neuroanaesthesia
Neuroanaesthesia Office,
6th Floor, A Block,
Christian Medical College, Ranipet Campus,
Vellore, Tamil Nadu
Vellore TAMIL NADU 632517 India |
| Phone |
9880626679 |
| Fax |
|
| Email |
NANDIVINAYAKAB@yahoo.in |
|
Details of Contact Person Scientific Query
|
| Name |
Georgene Singh |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College |
| Address |
Department of Neuroanaesthesia,
Neuroanaesthesia Office,
6th Floor, A Block,
Christian Medical College, Ranipet Campus,
Vellore, Tamil Nadu
Vellore TAMIL NADU 632517 India |
| Phone |
9443292504 |
| Fax |
|
| Email |
Georgenesingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nandi Vinayaka B |
| Designation |
Senior resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Neuroanaesthesia
Neuroanaesthesia Office,
6th Floor, A block,
Christian Medical College, Ranipet Campus
Vellore, Tamil Nadu
Vellore TAMIL NADU 632517 India |
| Phone |
9880626679 |
| Fax |
|
| Email |
NANDIVINAYAKAB@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College, Vellore, Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandi Vinayaka B |
Christian Medical College, Ranipet Campus |
Neurosurgery Theater,
4th Floor, B Block,
CMC Hospital, Ranipet Campus, Vellore TAMIL NADU |
9880626679
nandivinayakab@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ReviewBoard, Christian Medical College, Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective craniotomy or craniectomy for brain tumor resection. |
|
| ExclusionCriteria |
| Details |
GCS less than 15
Patients refusal
Patients on other steroids other than Dexamethasone
Recent Hospitalisation
Renal impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
Preoperative period, Intraoperative period, post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative Noradrenaline Requirement |
Till ICU stay |
| Lactate values |
Pre and Post surgery |
| intraoperative hypoglycemia and hyperglycemia episodes |
hypoglycemia 80mg per ml
hyperglycemias 180mg per ml |
| Postoperative hypo and hyperglycemias |
Hypoglycemia 80mg per ml
Hyperglycemia 180mg 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
karnofskys performance score 100 to 0 |
| Quality of Life as assessed by QoR 15 Questionnaire |
30 day QoR 15 questionnaire |
|
|
Target Sample Size
|
Total Sample Size="350" Sample Size from India="350"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
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