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CTRI Number  CTRI/2024/04/066005 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Recovery in planned neurosurgery in a group of patients  
Scientific Title of Study   Enhanced recovery in elective supratentorial craniotomies- a randomised controlled study 
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 Magimairaj  
Designation  Senior Consultant, Department of Anaesthesiology 
Affiliation  SIMS Hospitals 
Address  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9840757749  
Fax    
Email  mdavidjayapal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Magimairaj  
Designation  Senior Consultant, Department of Anaesthesiology 
Affiliation  SIMS Hospitals 
Address  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9840757749  
Fax    
Email  mdavidjayapal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Magimairaj  
Designation  Senior Consultant, Department of Anaesthesiology 
Affiliation  SIMS Hospitals 
Address  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9840757749  
Fax    
Email  mdavidjayapal@gmail.com  
 
Source of Monetary or Material Support  
SIMS Hospitals - institute of neuroscience  
 
Primary Sponsor  
Name  SIMS Hospitals 
Address  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026 
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 Magimairaj  SIMS Hospitals   Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026
Chennai
TAMIL NADU 		 9840757749

mdavidjayapal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERAS protocol   Abstinence from smoking and alcohol for 4 weeks before surgery, proton pump inhibitors preop, fasting 6h for light non fatty meal and 2h for clear liquids, scalp block, lung protective strategies, multimodal analgesia, early post op mobilisation and early discharge  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1 and 2, patients admitted for elective craniotomy for a single intracranial supratentorial lesion  
 
ExclusionCriteria 
Details  ASA 3 and 4, patients with major comorbid conditions, obese individuals with BMI more than or equal to 30, patients with drug allergies or egg allergy, patients participating in any other clinical studies, patient with major neurological deficits 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of hospital stay and total hospitalisation cost   From admission to discharge  
 
Secondary Outcome  
Outcome  TimePoints 
Readmission rates, postoperative complications, postoperative pain scores, perioperative opioid consumption, length of ICU , duration of drainage tube, time to first oral intake, postoperative functional recovery status   30 days from day of discharge  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/05/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mdavidjayapal@gmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 13-05-2060?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The use of ERAS protocol in the study group of patients who satisfy inclusion criteria and determination of duration of hospital stay and total hospitalisation costs when compared to the control group of standard protocol. Duration of length of hospital stay and costs compared along with readmission rates  
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