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CTRI Number  CTRI/2025/11/097980 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Analysis of the amount of energy used during general anaesthesia in elderly and young adults. 
Scientific Title of Study   Change in energy expenditure normalized to fat free mass during general anesthesia in elderly and young adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit V 
Designation  Postgraduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of Anaesthesiology, 6th floor Sri Ramachandra Medical Center Sri Ramachandra Institute of Higher Education and Research Porur

Chennai
TAMIL NADU
600116
India 
Phone  9994060181  
Fax    
Email  rohitranka16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SREE KUMAR E J  
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of Anaesthesiology, 6th floor Sri Ramachandra Medical Center, Sri Ramachandra Institute of Higher Education and Research Porur

Chennai
TAMIL NADU
600116
India 
Phone  8056564566  
Fax    
Email  sreekumardr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SREE KUMAR E J  
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of Anaesthesiology, 6th floor Sri Ramachandra Medical Center, Sri Ramachandra Institute of Higher Education and Research Porur

Chennai
TAMIL NADU
600116
India 
Phone  8056564566  
Fax    
Email  sreekumardr@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Rohit V 
Address  Department of Anaesthesiology, Sri Ramachandra Institute of Higher Education and Research Porur Chennai 
Type of Sponsor  Other [Individual] 
 
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 Rohit V  Sri Ramachandra Institute of Higher Education and Research   Department of Anaesthesiology, 6th floor, Sri Ramachandra Medical Center, Sri Ramachandra institute of higher education and research, Porur
Chennai
TAMIL NADU 
9994060181

rohitranka16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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  Elderly Energy expenditure  Energy expenditure during general anesthesia is calculated from displayed values of end-tidal oxygen, fraction of inspired oxygen and endtidal carbondioxide in elderly.  
Comparator Agent  Young Energy expenditure   Energy expenditure during general anesthesia is calculated from displayed values of end-tidal oxygen, fraction of inspired oxygen and endtidal carbondioxide in young patients. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  15 patients aged 20 to 40 years of either sex and 15 patients aged more than 65years belonging to ASA status I, II, scheduled for non-laparoscopic urological and gynaecological surgeries will be recruited.  
 
ExclusionCriteria 
Details  21-64 years
ASA III
BMI more than 35 kg per m2
Respiratory pathologies
Beta blockers
Musculoskelatal pathologies/ Patients with difficulty in ambulation
Difficult airway
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in energy expenditure in relation to the fat free mass between elderly and young adults during general anaesthesia  Every 5 minutes post-intubation intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Change in energy consumption with temperature between elderly and young adults during general anaesthesia  Preoperative and 2 hours after completion of surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/12/2025 
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 - NO
Brief Summary  

Fat free mass will be measured using foot to foot bioimpedance analysis followed by standard preoperative investigations. The six minute walk test will be explained to each patient and separate consent will be obtained. The 6MWT is a simple practical test that measures the distance a patient can walk in six minutes on a flat hard surface reflecting submaximal functional capacity. It involves global physiological responses and allows for self paced walking making it suitable for assessing daily functional capacity. On the day of surgery standard monitors will be applied and anesthesia will be induced and maintained with propofol fentanyl and vecuronium. An endotracheal tube 7 or 8 mm ID will be used and mechanical ventilation will be set based on predicted body weight and endtidal CO2 between 35 and 40 mmHg. Minute ventilation will be calculated using the Holliday Segar formula. Depth of anesthesia during intubation will be maintained using propofol. Intraoperative monitoring will include temperature and low flow anesthesia of 500 mL per min will be initiated with sevoflurane to reach a minimum alveolar concentration of 0.8 supported by propofol until the desired MAC is achieved. Alarm limits will be set for ventilatory parameters. The following variables will be recorded every five minutes until the end of surgery namely MV temperature heart rate systolic blood pressure mean arterial pressure diastolic blood pressure end tidal oxygen fraction of inspired oxygen and EtCO2. Postoperatively patients will be observed in the post anesthesia care unit for at least one hour with rescue analgesia administered as 0.5 mcg per kg fentanyl if needed. Intraoperative opioid consumption blood loss and fluid requirements will be documented. Relevant time points such as post induction incision and end of surgery will be noted. Energy expenditure will be calculated using Weirs equation.

 
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