| CTRI Number |
CTRI/2024/11/076102 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| 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 effects of two methods of anesthesia,total intravenous anesthesia and inhalational anesthesia on neuronal and systemic inflammation due to brain injury in patients with brain haemorrhage. |
|
Scientific Title of Study
|
The Effect Of Total Intravenous Anesthesia And Inhalational Anesthesia On Neuronal And Systemic Inflammation Secondary to Early Brain Injury In Patients with Aneurysmal
Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial (TIESAH) |
| Trial Acronym |
NIL |
|
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 Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
Department of Neuroanesthesiology
Room no:3714
7th Floor,C Block
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9495239765 |
| Fax |
|
| Email |
drajay@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sravan Sreekumar |
| Designation |
Senior Resident |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
Department of Neuroanesthesiology
Room no: 3402
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08921439538 |
| Fax |
|
| Email |
sraones008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sravan Sreekumar |
| Designation |
Senior Resident |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| Address |
Department of Neuroanesthesiology
Room no: 3402
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08921439538 |
| Fax |
|
| Email |
sraones008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute for Medical Sciences and Technology,Division of academic affairs,Room no 4,Trivandrum |
|
|
Primary Sponsor
|
| Name |
Academic division,Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
| 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 Tirunal Institute for Medical Sciences and Technology |
Neurosurgery OT and Neurosurgical ICU,
4th floor,Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram - 695011, Kerala, India
Thiruvananthapuram
KERALA |
9495239765
drajay@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute of Medical Sciences and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol based Total intravenous anaesthesia |
After preoxygenation with 100% oxygen for 3-5 minutes, Inj.Propofol 2-3 mg/kg titrated to BIS target of 30-40, 2 mcg/kg intravenous fentanyl followed by Inj. Vecuronium 0.08-0.1mg/kg after confirmation of bag and mask ventilation will be given for induction of anaesthesia.For maintanence Inj.Propofol 100- 300 mcg/kg/min intravenous infusion and Inj. Fentanyl 2 mcg/kg intravenous infusion
titrated to maintain a BIS value around 40-50 will be used.Duration of intervention depends on duration of surgery,usually 4-6 hours.
|
| Comparator Agent |
Sevoflurane based inhalational anaesthesia. |
After preoxygenation with 100% oxygen for 3-5 minutes, Inj. Thiopentone sodium 3-5 mg/kg titrated to BIS of 30-40, 2 mcg/kg intravenous fentanyl followed by Inj. Vecuronium 0.08- 0.1mg/kg after confirmation of bag and mask ventilation will be given for induction of anaesthesia.For maintanence Sevoflurane will be kept in order to maintain a MAC of 0.8 -1, titrated to maintain a BIS value around 40-50.Duration of intervention depends on duration of surgery,usually 4-6 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologist (ASA) physical status class I- IV (class III & IV due
to SAH)
2.Both gender
3Age 18-65 years, undergoing interventions for acute aSAH in the neurosurgery operation
theatre or IR lab.
4.Patient’s or legally responsible relative’s consent |
|
| ExclusionCriteria |
| Details |
1.ASA class III, IV (due to other systemic comorbidities), V
2.Severe or uncompensated cardiovascular, renal, hepatic or endocrine disease
3.Pregnancy, postpartum, lactating females
4.Drug allergy to Propofol or Fentanyl
5.Refusal to consent by patient or legally responsible relative.
6.Patients who are intubated and on mechanical ventilation
7.Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the levels of neuroinflammatory markers and systemic inflammatory markers pre and post anaesthesia exposure in patients undergoing interventions for acute aneurysmal subarachnoid haemorrhage. |
21 months for recruitment
3 months for data analysis and compilation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the correlation of neuronal and systemic inflammatory markers with neurological and cognitive outcome in patients undergoing interventions for acute aneurysmal subarachnoid haemorrhage |
21 months for recruitment
3 months for data analysis and compilation. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="2"
Months="0"
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
|
We plan to conduct a prospective randomized controlled trial to evaluate the effects of anesthetic agents on neuronal and systemic inflammation secondary to early brain injury in patients with acute aneurysmal subarachnoid haemorrhage undergoing interventions under Propofol based total intravenous anaesthesia versus Sevoflurane based inhalational anaesthesia. |