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CTRI Number  CTRI/2018/04/013247 [Registered on: 13/04/2018] Trial Registered Retrospectively
Last Modified On: 12/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   EARLY RECOVERY AFTER BRAIN SURGERY  
Scientific Title of Study   ENHANCED RECOVERY AFTER SURGERY(ERAS) IN ELECTIVE CRANIOTOMIES – A PROSPECTIVE COHORT STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ANIRUDH ELAYAT 
Designation  JUNIOR RESIDENT(academic) 
Affiliation  All India Institute Of Medical Sciences , Bhubaneswar 
Address  DEPARTMENT OF ANESTHESIOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR
DEPARTMENT OF ANESTHESIOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751019
India 
Phone  9495962127  
Fax    
Email  anirudhunnie7741@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUKDEV NAYAK 
Designation  HOD DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  All India Institute Of Medical Sciences , Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences Bhubaneswar – 751019

Khordha
ORISSA
751019
India 
Phone  9438884041  
Fax    
Email  sukdvnayak@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ANIRUDH ELAYAT 
Designation  JUNIOR RESIDENT(academic) 
Affiliation  All India Institute Of Medical Sciences , Bhubaneswar 
Address  DEPARTMENT OF ANESTHESIOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES , BHUBANESWAR
DEPARTMENT OF ANESTHESIOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751019
India 
Phone  9495962127  
Fax    
Email  anirudhunnie7741@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar , Sijua ,Patrapada , Dumduma , 751019 
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 
ANIRUDH ELAYAT  All India Institute Of Medical Sciences  Neurosurgery ward (opp private ward I) and post operative surgical ICU (inside old OT complex), AIIMS hospital Casuality block , Sijua , Patrapada, Dumduma,Bhubaneswar , Orissa 751019
Khordha
ORISSA 		 9495962127

anirudhunnie7741@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Medical Sciences Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  all ASA 1 and 2 patients above 18 yrs posted for elective craniotomies for supratentorial space occupying lesions will be recruited for study, (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NON ERAS GROUP  After obtaining written informed consent standard NPO guidelines will be followed. No pre operative flupiritine tablets or maltodextrin drinks will be given. Scalp blocks will not be given. Time taken for extubation and shift from ICU will be noted and compared with ERAS group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Adult patients (>18 years)
2.ASA 1 and 2 functional status
3.Patients undergoing elective craniotomies for supra-tentorial space occupying lesions.
 
 
ExclusionCriteria 
Details  1.Refusal to give consent
2.GCS (Glasgow Coma Scale) score <13
3.Uncontrolled diabetics

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To compare the conventional and ERAS protocol on the post-operative length of ICU stay in patients undergoing elective craniotomies.   1.Total duration of stay in ICU
2.Time of discharge from ICU 
 
Secondary Outcome  
Outcome  TimePoints 
1.If there was prolonged stay in the ICU 48 hours in both the groups, what was the cause – ie whether it was surgical or non- surgical cause that lead to the prolongation?
2.Whether ERAS protocol had led to decrease in the consumption of opioids and / decreased cumulative analgesic use ?
3.The level of glycemic control in ERAS patients as compared to conventional protocol.
4.Whether ERAS protocols lead to an overall decrease in length of hospital stay?

 		 1. 2nd hourly VAS scoring (for first 48 hrs in ICU)
2. 8th hourly blood glucose monitoring (for first 48 hrs in ICU)
3. Cumulative analgesic dosage
4. Cumulative insulin dosage
5. Time of discharge from ICU
6. Time of removal of drains/Foley’s catheter
7. Total duration of stay in ICU
8. Reason for stay in ICU48hrs(if any)
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/10/2017 
Date of Study Completion (India) 12/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/11/2018 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Enhanced Recovery After Surgery protocols have already being established in the field of gastro- enterology and and urological surgeries. Though ERAS guidelines for neurosurgery exist ,no study has been conducted so far to evaluate the implementation of ERAS protocols to neurosurgeries. Here we attempt to implement ERAS protocols  starting from preoperative councelling , carbohydrate preloading , preemptive analgesia , scalp block and scalp infiltration , near zero fluid balance , temperature and glycemic monitoring ,restricted intra and postoperative use of opiods and encouraging removal of unwanted drains and cathethers to 31 cases of supratentorial space occupying lesions posted for elective craniotomies and compare with 31 matched controls done under conventional protocols. The comparison will be made on the basis of length of duration of stay in the ICU , post operative pain scores , post operative glycemic status and overall length of stay in hospital .This will be a prospective cohort study and will give an insight as to the efficacy of ERAS programs with neurosurgery.  
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