| CTRI Number |
CTRI/2023/08/056679 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To study the blood flow in the brain during surgery with the help of ultrasound. |
|
Scientific Title of Study
|
Comparison of Cerebral Blood Flow During Recovery Between Total Intravenous Anesthesia Versus Balanced Anesthesia Technique in Patients Undergoing Elective Supratentorial Craniotomy: A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Selvendiran P |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical College, vellore |
| Address |
Department of Neuroanaesthesia,
Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9566947689 |
| Fax |
|
| Email |
selva224@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Keta Thakkar |
| Designation |
Associate professor |
| Affiliation |
Christian Medical College, vellore |
| Address |
Department of Neuroanaesthesia,
Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9879520603 |
| Fax |
|
| Email |
keta0819@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Selvendiran P |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical College, vellore |
| Address |
Department of Neuroanaesthesia,
Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9566947689 |
| Fax |
|
| Email |
selva224@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Vellore. |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College, I
da scudder road, Vellore- 632002.
Tamilnadu. |
| 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 |
| SELVENDIRAN |
Christian Medical College |
Department of Neuroanaesthesia, CMC Vellore, Ranipet Campus .632002. Vellore TAMIL NADU |
9566947689
selva224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BALANCED ANAESTHESIA |
Group B will receive Propofol schnider effect site concentration of 2-3 titrated to a BIS of 40-60 and Fentanyl 1-2 mcg/kg/hr along with Sevoflurane MAC of 0.5. |
| Comparator Agent |
TIVA ( Total Intravenous Anaesthesia) |
Group A will receive infusion of Propofol schnider model effect site concentration of 3-4 titrated to a BIS of 40-60 and Fentanyl 1-2 mcg/kg/hr without volatile anaesthetic agent.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 17-65years
2. Supratentorial tumor with no clinical /radiological features of raised ICP-MLS<1 cms
3. ASA 1,2,3
|
|
| ExclusionCriteria |
| Details |
1. Emergency Procedure
2. Severe cardiovascular or respiratory disease (ASA grade ≥3),
3. Poor visulalization of MCA due to inadequate temporal window,
4. Pregnancy,
5. Allergies to Propofol,
6. History of Renal, Liver disease,
7. Psychiatric illnesses,
8. Patient refusal,
9. Awake Craniotomy,
10. GCS<15
11. Preoperative Cognitive defects/Vision Loss
12. Symptomatic Raised Intracranial Pressure with hypertension and Bradycardia
13. Patients on ventilator preoperatively
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of anaesthesia, which is either TIVA with propofol or balanced anesthesia with Sevoflurane on cerebral blood flow by transcranial doppler (TCD) measurement of Mean Flow Velocity (MFV) of middle cerebral artery (MCA) in patients undergoing elective supratentorial craniotomy. |
1. baseline before anaesthesia,
2. after intubation
3. postoperatively within 30 minutes after extubation
4. postoperatively within 60 minutes after extubation and
5. on postoperative day 2 - 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Perioperative measurement of cerebral autoregulation
2. Intra-operative hemodynamic profile
3. Time taken to attain preoperative GCS |
1) Cerebral autoregulation using THRT test in the preoperative period, immediate (60 minutes) & late (3-6 days) postoperative period.
2) Intraoperative Haemodynamic Profile
HR & MAP will be recorded every 15 minutes from the baseline throughout the surgery, at the time of discontinuation (D/C) of IV or volatile agent (VA), at the time of emergence, till 60 minutes after extubation & post-operative between day 2-5.
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
28/08/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Craniotomies have a higher rate of postoperative complications than the general surgical population and adversely affect the quality of life. Moreover, patients undergoing craniotomy develop postoperative cognitive and physical deficits which makes it difficult to assess the postoperative quality of recovery. With the advances in imaging and surgical techniques, the focus has shifted from merely eliminating pathology to ensuring maximal functional recovery as early as possible. Hence, it is important that anaesthetic techniques in addition to providing favorable intraoperative hemodynamics and brain relaxation must ensure a good quality of recovery to the patient as perceived by the patient. It has been hypothesized that different anaesthetic strategies have differential effects on cerebral blood flow (CBF) and metabolic demand (CMRO2). Both propofol and volatile agents reduce CMRO2, and propofol and volatile agents are both systemic vasodilators, although propofol has been shown to reduce CBF, while volatile agents increase CBF. Also, volatile agents impair cerebral autoregulation in a dose-dependent manner, whereas propofol does so to a lesser extent. It is plausible that these divergent cerebrovascular properties have differing effects on the CBF and may impact outcomes in patients undergoing supratentorial craniotomies. We aimed to evaluate the effect of anaesthesia, which is either TIVA with propofol or balanced anaesthesia with Sevoflurane on cerebral blood flow by transcranial doppler (TCD) measurement of Mean Flow Velocity (MFV) of the middle cerebral artery (MCA) in patients undergoing elective supratentorial craniotomy. |