| CTRI Number |
CTRI/2024/10/075063 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of one anaesthetic drug with another on its effect of blood flow and oxygenation of brain in patients undergoing brain surgery for intracranial space occupying lesions: A
Randomized Double-Blinded Controlled Trial |
|
Scientific Title of Study
|
Comparison of the effect of ketofol versus propofol on cerebral blood flow and cerebral
oxygenation in patients undergoing neurosurgery for supratentorial intracranial space occupying lesions: A
Randomized Double-Blinded 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 |
Ranganatha Praveen C S |
| Designation |
Additional Professor |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences and Technology |
| Address |
Division of neuroanaesthesia and critical care, SCTIMST, Trivandrum
Thiruvananthapuram KERALA 695011 India |
| Phone |
9855746254 |
| Fax |
|
| Email |
drrpcs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ranganatha Praveen C S |
| Designation |
Additional Professor |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences and Technology |
| Address |
Division of neuroanaesthesia and critical care, SCTIMST, Trivandrum
Thiruvananthapuram KERALA 695011 India |
| Phone |
9855746254 |
| Fax |
|
| Email |
drrpcs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Naveen Vivek S |
| Designation |
Senior Resident |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences and Technology |
| Address |
Division of neuroanaesthesiology and critical care, SCTIMST, Trivandrum
Thiruvananthapuram KERALA 695011 India |
| Phone |
9626625825 |
| Fax |
|
| Email |
dr.nv92@gmail.com |
|
|
Source of Monetary or Material Support
|
| SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY
THIRUVANANTHAPURAM
KERALA
INDIA 695011 |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, TRIVANDRUM,KERALA
Thiruvananthapuram, Kerala-695011, India |
| 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 Naveen Vivek |
Hospital,Sree Chitra Tirunal Institute for Medical Sciences and Technology |
ROOM NO. 3402, 4TH FLOOR, BLOCK 3, DEPARTMENT OF NEUROANAESTHESIA. Thiruvananthapuram KERALA |
9626625825
dr.nv92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY ,TRIVANDRUM,THIRUVANANTHAPURAM 695011 KERALA ,INDIA, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D430||Neoplasm of uncertain behavior ofbrain, supratentorial, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketofol |
Ketamine+Propofol as anaesthetic agent.50 ml syringe containing 40 ml of propofol (10mg/ml) and 8 ml of ketamine (10 mg/ml). The dose will be titrated according to neuromonitoring and hemodynamics. It will be stopped at the end of surgery. |
| Comparator Agent |
Propofol |
Propofol as an anaesthetic agent. The drug will be prepared in a 50 ml syringe containing 48 ml of propofol (10 mg/ml). The dose will be titrated according to neuromonitoring and hemodynamics. It will be stopped at the end of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients aged 18-60 years undergoing supratentorial intracranial space-occupying lesion surgery in neurosurgery operation theatre at Sree Chitra Tirunal Institute for Medical Sciences and Technology.
1. ASA (American Society of Anaesthesiologists) classes 1 and 2
2. GCS 15 before the surgery
|
|
| ExclusionCriteria |
| Details |
Minor, pregnant woman, neonates and patients incompetent to give consent will not be included in the study |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the cerebral blood flow using TCD and cerebral oxygenation using NIRS between the two groups |
a) Baseline-Before induction of anaesthesia (T0)
b) 15mins Post Induction (T1)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative haemodynamics, brain bulge, use of opioids and outcome at the time of discharge between the two groups. |
Baseline-T0, 15 mins Post-induction-T1, Head pin application-T2, Burr hole-T3, ICP measurement-T4, Craniotomy-T5, Bone flap removal-T6, Dural opening-T7, Tumour excision-T8, Dural closure-T9, Muscle suture-T10, Skin suture-T11. |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/10/2024 |
| 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="6" 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
|
The study will begin after obtaining the IEC approval. Patients posted for elective supratentorial intracranial space-occupying lesion surgery who satisfy the eligibility criteria will be included in the study. Written informed consent for participation in the study will be obtained from the patient. The randomization list will be computer-generated by a statistician using a blocked design. Allocation concealment will be achieved by packaging the study drug in serially numbered opaque envelopes marked with subject ID. These packets will be assembled by the OT technician/neuro anaesthetist who is not directly involved with the clinical trial. They will prepare the study drug according to the randomization list provided by the statistician. The neuro anaesthetists inducing the patient and involved in the intraoperative period will be unaware of the study drug being administered. The induction and maintenance will be based on the BIS values. Hence, the intraoperative neuro anesthetist collects the parameters, and the patient will be blinded to the study to avoid bias. Accordingly, they will be randomized into two groups : Group K: Patients will receive ketamine and propofol infusion Group P: Patients will receive propofol infusion. Preop- Bilateral TCD flow velocity of middle cerebral artery (MCA) will be recorded by using TCD probe before anaesthesia induction & NIRS optodes will be applied to the patient’s forehead bilaterally and the baseline readings will be noted. Before anaesthesia induction, baseline hemodynamic parameters including heart rate, mean arterial pressure (MAP), oxygen saturation (SPO2), End tidal carbon dioxide – ETCO2 (after asking the patient to take normal respiration) will be noted. Depending on the randomisation, the maintenance anaesthetic agent would be either propofol in group P or ketofol in group KP to achieve the BIS of 40-60. Upon completion of the surgery, the patients will be assessed for extubation at the discretion of the attending anaesthetist and as per standard protocol. |