| 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
|
|
|
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
|
|
|
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
|
|
|
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. |