| CTRI Number |
CTRI/2024/06/068917 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effect of using different low flows of anaesthesia using Desflurane anaesthesia gas on oxygen concentration inhaled by Obese patients during planned surgery |
|
Scientific Title of Study
|
Effect of low flow and minimal flow Desflurane anaesthesia on inspired oxygen concentration in obese patients undergoing elective surgery under general anaesthesia: A Randomised parallel group 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 Sherigar Mahesha Ravi |
| Designation |
Post Graduate |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Anaesthesiology Maulana Azad Medical College and Lok Nayak hospital, Bahadur Shah Zafar Marg New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8971315807 |
| Fax |
|
| Email |
drsherigarmahesharavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munisha Agarwal |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Maulana azad medical college |
| Address |
Room no 307 BL Taneja block Maulana Azad medical college and Lok Nayak hospital, 2 Bahadur Shah Zafar Marg New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123238058 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sherigar Mahesha Ravi |
| Designation |
Post Graduate |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Anaesthesiology and Intensive care, Maulana Azad Medical College and Associated Lok Nayak Hospital New Delhi
Central
DELHI
110002
India |
| Phone |
8971315807 |
| Fax |
|
| Email |
drsherigarmahesharavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college and lok Nayak hospital 2 Bahadur Shah Zafar Marg New Delho -110002 India |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Department of Anaesthesiology and Intensive care, Maulana Azad Medical College and Lok Nayak hospital 2 Bahadur Shah Zafar Marg New Delhi 110002 India |
| 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 |
| Sherigar Mahesha Ravi |
Lok Nayak Hospital New Delhi |
OT Block , Department of Anaesthesiology Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg New Delhi Central Delhi
Central
DELHI |
8971315807
drsherigarmahesharavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
| Comparator Agent |
Low flow anaesthesia |
Fresh gas flow is kept at 1 litre per minute after 10 minutes of Induction till 180 minutes/end of surgery |
| Intervention |
Minimal-flow Anesthesia |
Fresh gas flow is kept at 0.5 litres per minutes after 10 minutes of Induction till 180 minutes/end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA Physical status of I and II.
2.Duration of Low flow or minimum flow anaesthesia of at least 90 minutes. |
|
| ExclusionCriteria |
| Details |
1. Patients with known history of hepatic, renal or cardiovascular disease.
2. Patients with preoperative pulmonary dysfunction, acute or chronic lung disease. 3.Pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in inspired oxygen concentration in low flow and minimal flow desflurane anaesthesia.
|
After 10 minutes of Low flow anaesthesia for every 15 minutes interval till the end of surgery/ 180 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total oxygen consumed per hour in low flow and minimal flow anaesthesia.
|
After 10 minutes of Low/minimal flow anaesthesia for every 15 minutes interval till the end of surgery /180 minutes |
Total Desflurane consumed per hour in low flow and minimal flow anaesthesia.
|
After 10 minutes of Low/minimal flow anaesthesia for every 15 minutes interval till the end of surgery/ 180 min |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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="0"
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
|
Any technique that employs Fresh Gas Flow that is less than alveolar ventilation can be designated as low flow anaesthesia.Here the fresh gas flow is kept to a maximum of 1 lpm.The principle is to replenish the consumed gas with as minimal fresh gas as possible thereby making it physiologically, economically beneficial and sustainable. Minimal flow anaesthesia is subtype of low flow anaesthesia with maximum FGF of 0.5 lpm.One of the potential risks associated with low flow anaesthesia is risk of hypoxia.During low flow anaesthesia, as the flow rate is decreased, the gradient between oxygen content of blood and inspired oxygen concentration of gas mixture increases.With increase in metabolic demands, the oxygen consumption may exceed the total delivered oxygen and lead to hypoxic mixture to the patient.There are few studies that have compared the change in delivered gas consumption during minimal flow and low flow anesthesia technique with desflurane in obese population.Hence , we wish to study the effect of low flow and minimal flow desflurane anaesthesia on inspired oxygen concentration in obese patients with desflurane undergoing elective surgery under general anaesthesia |