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CTRI Number  CTRI/2022/01/039533 [Registered on: 18/01/2022] Trial Registered Prospectively
Last Modified On: 18/08/2022
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   Ketofol or Propofol, agent maintaining better haemodynamics in patients undergoing trans-sphenoidal pituitary surgery under total intravenous anaesthesia. 
Scientific Title of Study   A randomized control trial to evaluate the effects of Ketofol and Propofol on cerebral oxygenation in patients undergoing trans-sphenoidal pituitary surgery under total intravenous anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeshna Padhi 
Designation  senior resident 
Affiliation  AIIMS, New Delhi 
Address  3rd floor 297 Gautam Nagar Gautam Nagar Road
Department of Neuroanaesthesiology and Neurocritical care CNC AIIMS New Delhi
New Delhi
DELHI
110049
India 
Phone  9674858350  
Fax    
Email  drsudeshnapadhi123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Chatturvedi  
Designation  HOD 
Affiliation  AIIMS, New Delhi 
Address  CNC AIIMS New Delhi
Department of Neuroanaesthesiology and Neurocritical care CNC AIIMS New Delhi
New Delhi
DELHI
110049
India 
Phone  9871045824  
Fax    
Email  c.arvind61@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Sudeshna Padhi 
Designation  senior resident 
Affiliation  AIIMS, New Delhi 
Address  3rd floor 297 Gautam Nagar Gautam Nagar Road
Department of Neuroanaesthesiology and Neurocritical care CNC AIIMS New Delhi
New Delhi
DELHI
110049
India 
Phone  9674858350  
Fax    
Email  drsudeshnapadhi123@gmail.com  
 
Source of Monetary or Material Support  
Dept of Neauroanaesthesia and Neurocritical care, CNC, AIIMS , New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Dept of Neuroanaesthesia CNC AIIMS New Delhi 
Type of Sponsor  Government medical college 
 
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 Sudeshna Padhi  AIIMS, New Delhi   Room No-12, 6th floor, Dept of NeuroAnaesthesia, CNC.
New Delhi
DELHI 		 9674858350

drsud456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics comittee for Postgraduate Research, AIIMS, Ansari Nagar New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D337||Benign neoplasm of other specifiedparts of central nervous system, (2) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ketofol  intravenous ketofol at rate of 2ml/kg, at induction & continuous infusion throughout surgery 
Comparator Agent  propofol  intravenous propofol at rate of 2ml/kg, at induction & continuous infusion throughout surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1, 2
Planned for elective endoscopic TNTS Pituitary Surgery 
 
ExclusionCriteria 
Details  Consent not given
Patients with history of previous pituitary surgery
Patients with psychiatric disorder
History of drug abuse
Poorly controlled hypertension
Ischaemic heart disease, valvular heart disease
History of lung diseases-COPD, Asthma
History of Renal diseases
History of liver diseases
Pituitary apoplexy
Morbidly obese ( BMI >40)
Pregnant patients
History of allergy to any of the planned anaesthetic medications of the study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare effects of ketofol versus propofol on cerebral oxygenation (rSO2) in patients undergoing TNTS Pituitary surgery   Baseline then Every 30min interval 
 
Secondary Outcome  
Outcome  TimePoints 
To compare between both drugs intraoperative haemodynamic parameters ( HR, MAP), intraoperative requirements of propofol and opioids, postoperative emergence  Baseline & every 30min 
 
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)   20/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Although there have been many studies on role of various intravenous anaesthetic agents on maintenance of intraoperative haemodynamics in neurosurgical patients but there has not been many studies comparing their role on maintenance of cerebral oxygenation. So, we plan to conduct this study to compare the effects of two anaesthetic regimen on cerebral oxygenation in patients undergoing TNTS pituitary surgery. In TNTS pituitary surgery the surgical approach is via transnasal and transsphenoidroute. This avoids open craniotomy with the advantage ofavoidance of major handling of brain tissue (like retractor applications) and intracranial vessels, thereby minimizing the effects of surgical factors on cerebral oxygenation. We hypothesize that use of ketofol as induction & maintenance agent will lead to better cerebral oxygenation compared to Propofol alone. 
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