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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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