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CTRI Number  CTRI/2024/02/062799 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE HOSPITAL BASED 
Study Design  Other 
Public Title of Study   Clinical study of impact of peri-operative anaesthetic management on early recovery after surgery (ERAS) for hepatic resections. 
Scientific Title of Study   Clinical study of impact of peri-operative anaesthetic management on early recovery after surgery (ERAS) for hepatic resections in a tertiary care hospital 
Trial Acronym  ERAS protocol for hepatic resection 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR TANUJ SHARMA 
Designation  JUNIOR RESIDENT 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9983505040  
Fax    
Email  DRTANUJSHARMA@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  DR AVNISH KUMAR BHARADWAJ 
Designation  PROFESSOR & HEAD OF THE DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  AVNISHBHARADWAJ1@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  DR AVNISH KUMAR BHARADWAJ 
Designation  PROFESSOR & HEAD OF THE DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  AVNISHBHARADWAJ1@GMAIL.COM  
 
Source of Monetary or Material Support  
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL Jaipur 
 
Primary Sponsor  
Name  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA 
Type of Sponsor  Private 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 TANUJ SHARMA  OT complex and ICU MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA
Jaipur
RAJASTHAN 
9983505040

DRTANUJSHARMA@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR RAJENDRA KUMAR SUREKHA, MEMBER SECRETARY IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K769||Liver disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arterial line  Arterial line for intraoperative beat to beat monitoring. 
Intervention  Epidural catheter   Placement of epidural catheter for post operative analgesia. 
Intervention  Internal jugular vein catheterization   IJV catheterization is done for goal directed fluid therapy and to monitor CVP. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient with American Society of anesthesiologists (ASA) Class I, II and III.
Patient posted for elective hepatectomy.
Invasive procedures: -
Epidural analgesia.
CVP monitoring via central line.
MAP monitoring via arterial line. 
 
ExclusionCriteria 
Details  BMI over 30
Uncontrolled comorbidities viz diabetes, hypothyroidism, hypertension, etc.
History of cerebrovascular accident.
Patient with known or newly diagnosed coagulopathy.
Pregnant patient 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Days of stay in hospital.
Early recovery after surgery. 
Days of stay in hospital.
Early recovery after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction of received care.
Reduce number of complications.
Re-intervention and re-admission rates.
Health related quality of life and physical activity of patients. 
Aims to accelerate patient recovery through creating a structured approach with defined components of care at each perioperative stage 
 
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)   25/02/2024 
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)   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 - NO
Brief Summary  
Enhanced recovery after surgery (ERAS): FAST TRACK SURGERY conceptualized by Prof. Henrik kehlet in order to early mobilization and recovery after surgery. ERAS concept gained considerable momentum globally. Enhanced recovery after surgery (ERAS) is an evidence-based approach to surgical care aimed at minimizing the stress of surgery and supporting patients to recover quickly through maintenance of normal physiology. ERAS protocol for hepatic resection pathway have been found to be safe and effective in patient undergoing liver resection, resulting in shortened postoperative stay, reduces mortality, re-admission rates and reduced costs. Aims to accelerate patient recovery through creating a structured approach with defined components of care at each perioperative stage (pre-, intra-, and post-).The key elements of ERAS include patient/family education, patient optimization prior to admission, minimal fasting that includes a carbohydrate beverage two hours before anesthesia, multimodal analgesia with appropriate use of opioids when indicated, return to normal diet and activities the day of surgery, and return of bowel function early.

A prospective, hospital based, observational study including all cases of liver resection in a time period between April 2023 to October 2024.

Data will be collected by using self design questionnaire.

Entire data would be entered into a Microsoft office software and appropriate statistical test will be applied and results will be calculated.
 
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