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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  
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 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  
Status 
Not Applicable 
 
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.

 
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