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CTRI Number  CTRI/2023/10/058436 [Registered on: 09/10/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of two methods of anesthesia, total intravenous anesthesia and inhalational anesthesia on neuroinflammation 
Scientific Title of Study   The Effect Of Total Intravenous Anesthesia And Inhalational Anesthesia On The Markers Of Neuronal And Systemic Inflammation In Patients Undergoing Resection Of Supratentorial Gliomas: A Prospective Randomized Controlled Trial ”  
Trial Acronym  TINSI TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AJAY PRASAD HRISHI 
Designation  Additional Professor 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram 
Address  Additional Professor Department of Neuroanesthesia Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  7012581920  
Fax    
Email  drajay@sctimst.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr AJAY PRASAD HRISHI 
Designation  Additional Professor 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram 
Address  Additional Professor Department of Neuroanesthesia Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  7012581920  
Fax    
Email  drajay@sctimst.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr SREEJA R 
Designation  Senior Resident 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram 
Address  Senior Resident Department of Neuroanesthesia Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9496833742  
Fax    
Email  drsreeajith@gmail.com  
 
Source of Monetary or Material Support  
Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, India 
 
Primary Sponsor  
Name  Sree Chitra Thirunal Institute of Medical Sciences and Technology 
Address  Academic Section,Sree Chitra Thirunal Institute of Medical Sciences and Technology , Thiruvananthapuram 
Type of Sponsor  Research institution and hospital 
 
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 AJAY PRASAD HRISHI  SREE CHITRA THIRUNAL INSTITUTE OF TECHNOLOGY  Department of neuroanesthesia Neurosurgery operation theatres- OT-1,2,3 and 4 Fourth floor Biochemistry lab for analysis of sample
Thiruvananthapuram
KERALA 
7012581920

drajay@sctimst.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC),SCTIMST, Thiruvanthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inhalational aneshtesia  Anesthesia will be induced with Thiopentone 5-7 mg/kg and maintained with sevoflurane 0.7-1.1minimum alveolar concentration (MAC) titrated to a BIS value of 40-50.  
Intervention  Total intravenous anesthesia  Anesthesia will be induced by target-controlled infusion (TCI) of propofol (Schneider pharmacokinetic model) with an initial effect site concentration set at 4-6 mcg/ml and maintenance at 2.8-4 mcg/ml. Moreover, the propofol concentration will be adjusted to target a bispectral index (BIS) value of 40-50. Duration of intervention depends on the duration of surgery, usually 4-5 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patient consent
2) ASA class I-II
3)Age 18-65 years, undergoing craniotomy for supratentorial glioma in the neurosurgery operation theatre
4)Preoperative Karnofsky Performance Scale of 70 or above 
 
ExclusionCriteria 
Details  1) ASA class III,IV, V
2) Severe or uncompensated cardiovascular, renal, hepatic or endocrine disease
3) Pregnancy, postpartum and lactating females
4) Drug allergy to Propofol
5) Refusal to consent by patient or next of kin
• patients with an active inflammatory process such as infection or immunologic illness known to increase the baseline immunologic markers,
• Emergency surgery
• Revision craniotomy at the same site
• Preoperative history of seizures.
• h/o preoperative cognitive dysfunction 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Changes in the blood level of neuron specific enolase measured before induction of anesthesia & at the end of surgery
2. Changes in the blood level of interleukin -6 measured before the induction of anesthesia & at the end of surgery
 
Before induction of anesthesia & after extubation

 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters- heart rate & invasive blood pressure, urine output, maximum allowable blood loss, estimated blood loss, & total fluid input.
1) Tumour type, size, location, grade of tumor, duration of surgery, duration of anaesthesia, days of ICU stay, and days of hospital stay.
2) POSTOPERATIVE PARAMETERS:
- Glasgow Outcome Scale
- CAM score
- Montreal cognitive assessment
- BCSI
 
IN ICU & 3 months after discharge 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 4 
Date of First Enrollment (India)   12/10/2023 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This study intends to evaluate which anaesthetic technique, propofol-based total intravenous anesthesia or sevoflurane-based inhalational anesthesia has a better neuronal and systemic anti-inflammatory profile. Glioma is a disease state with a high risk of morbidity and mortality. Thus, identifying the ideal anaesthetic agent will provide a better neurophysiological profile by suppressing neuronal and systemic inflammation in the perioperative period. A prospective randomized controlled  trial will be done to evaluate the inflammatory markers in patients undergoing craniotomy for supratentorial glioma under propofol-based intravenous anaesthesia and sevoflurane-based inhalational anesthesia  
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