| CTRI Number |
CTRI/2025/08/092764 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the environmental impact of two common anaesthetic drugs- sevoflurane and propofol on carbon dioxide emissions. |
|
Scientific Title of Study
|
Comparative quantification of carbon dioxide emissions associated with propofol and sevoflurane based anaesthesia |
| 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 Kulwant Kaur |
| Designation |
Junior resident |
| Affiliation |
Government Medical College, sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical college, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7973562770 |
| Fax |
|
| Email |
kulwantkaur0309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Jindal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical college, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohit604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Gupta |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical college, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646401899 |
| Fax |
|
| Email |
smartdeepileo86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, Block D, Level 5,Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin code- 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College, sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College, sector 32 , Chandigarh, India, Pin code- 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Kulwant Kaur |
Government Medical College, sector-32, Chandigarh |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
7973562770
kulwantkaur0309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, GMCH, Chandigarh |
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 |
Propofol based anaesthesia |
Anaesthesia will be provided using a continuous intravenous infusion of propofol, titrated to clinical response, along with 60 percent nitrous oxide and 40 percent oxygen at a total FGF of 2 litres per min. Depth of anaesthesia will be assessed using Bispectral Index or entropy monitoring, targeting a BIS or entropy range of 40–60. Total volume of propofol administered in ml, Number of ampoules opened, Volume of propofol wasted like drawn but not used will be noted. Carbon dioxide emissions will be calculated based on formulas. Once the surgery is complete, patient will be monitored for post-operative complications like allergic reactions, hypotension and rarely, propofol infusion syndrome. The total duration is approximately 1hr i.e the time till the surgery will take place.
|
| Comparator Agent |
Sevoflurane based anaesthesia |
Anaesthesia will be provided using sevoflurane delivered via a calibrated vaporizer, with 60 percent nitrous oxide and 40 percent oxygen, and a total fresh gas flow of 2 litres per min. Depth of anaesthesia will be assessed using Bispectral Index or entropy monitoring, targeting a BIS or entropy range of 40–60. Volume of each bottle of sevoflurane will be noted. Carbon dioxide emissions will be calculated based on formulas. Once the surgery is complete, patient will be monitored for post-operative complications like post-operative nausea and vomiting, malignant hyperthermia etc. The total duration will be approximately 1hr i.e the time till the surgery will take place.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 years and above, with ASA PS I, II or III undergoing elective laparoscopic cholecystectomy under general anaesthesia will be recruited.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a previous history of malignant hyperthermia.
2. Known allergy to inhalation anaesthetics/ Propofol (egg Allergy)
3. Development of significant intraoperative events like bronchospasm, hypotension and arrythmias or any other hemodynamic instability.
4. Emergency surgeries or surgeries conducted under regional anaesthesia
5. Surgeries with incomplete or missing data
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the carbon equivalent emissions in kg calculated from use of propofol, sevoflurane and nitrous oxide. These emissions will be calculated based on standarised emission conversion factors for each anaesthetic agent, reflecting the carbon footprint associated with both anaesthesia techniques like propofol and sevoflurane during elective laparoscopic cholecystectomy surgeries. |
After every 15 minutes post induction till the completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Consumption of Anaesthetic Agents per Case:
The total volume of propofol, sevoflurane, & nitrous oxide consumed per case will be estimated & compared between the two anaesthesia techniques.
Wastage of Propofol per Case:
The volume of propofol wasted (drawn but unused, or residual) during the procedure will be quantified for the propofol group.
Cost of Anaesthetic Agents per Case:
The direct cost of anaesthetic agents (propofol, sevoflurane, & nitrous oxide) used per case will be estimated & compared between the two groups.
|
After every 15 minutes post induction till the completion of surgery. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Healthcare significantly contributes to climate change, with anaesthesia alone accounting for 3 percent of healthcare-related greenhouse gas emissions. Volatile anaesthetics like desflurane, isoflurane, and sevoflurane have high global warming potential, with desflurane being the most harmful. Nitrous oxide also contributes to ozone depletion. Total intravenous anaesthesia, particularly with propofol, offers lower environmental impact, though concerns exist regarding propofol’s ecotoxicity, persistence, and improper disposal. Studies show TIVA emits fewer carbon equivalents compared to inhalational techniques, especially in short surgeries and paediatric cases. However, propofol waste can be high, though manageable by using smaller syringes. Some studies highlight cost-effectiveness of low-flow inhalational techniques and suggest that both environmental and economic burdens can be reduced by avoiding desflurane or nitrous oxide, minimizing fresh gas flows, and managing drug waste efficiently. Despite studies evaluating patient safety, cost, and efficacy across anaesthetic techniques, few have thoroughly assessed the environmental or economic differences between TIVA and inhalational agents like sevoflurane. AIM is to compare and quantify carbon dioxide emissions associated with propofol and sevoflurane-based anaesthesia when both are titrated to maintain depth of anaesthesia using BIS or Entropy. OBJECTIVE is to measure and compare total carbon dioxide emissions produced during administration of propofol and sevoflurane METHODOLOGY This study involves random allocation of patients into two groups: Group A is Sevoflurane maintenance and Group B is Propofol maintenance, following a standardized anaesthetic induction protocol using fentanyl, propofol, and vecuronium. Demographic and routine preoperative data will be collected. After induction, anaesthesia will be maintained with either sevoflurane or continuous propofol infusion, both using 60 percent nitrous oxide and 40 percent oxygen at a fresh gas flow of 2 litres per min. Depth of anaesthesia will be monitored using BIS or entropy, targeting a range of 40–60. Data on drug usage like quantities, vials used, and duration of surgery will be collected for environmental analysis. Carbon dioxide emissions from both induction and maintenance phases will be calculated using standardized formulas. For Group A, calculations will include fresh gas flow, vaporizer settings, and volume of liquid sevoflurane used. For Group B, total administered and wasted propofol volume will be noted. Nitrous oxide emissions will be calculated in both groups. It also includes assessing propofol wastage by measuring the difference between drawn and administered volume, accounting for losses in syringes and needle hubs and differences in cost in both the groups. The study will also evaluate post-operative complications/side effects of the drugs administered. PRIMARY OUTCOME will be the mean carbon dioxide equivalent emissions calculated from use of propofol, sevoflurane and nitrous oxide. These emissions will be calculated based on standardised emission conversion factors for each anaesthetic techniques like propofol and sevoflurane during elective laparoscopic cholecystectomy surgeries. SECONDARY OUTCOMES include Total volume of propofol, sevoflurane, and nitrous oxide consumed per case will be estimated and compared between two anaesthesia techniques. The volume of propofol wasted, drawn but unused,or residual, during the procedure will be quantified for the propofol group. The direct cost of anaesthetic agents like propofol, sevoflurane, and nitrous oxide used per case will be estimated and compared between two groups. |