| 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
|
|
|
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
|
|
|
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 |