| CTRI Number |
CTRI/2025/04/084594 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of equilibriation point of Desflurane and Sevoflurane as a change over point in low flow anesthesia |
|
Scientific Title of Study
|
Use of Equilibriation point of Sevoflurane and Desflurane as a changeover point to low flow anesthesia- a randomised prospective comparative study on Breast cancer surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Nataraj Upadhyay |
| Designation |
Post graduate |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 105, Operation theater complex, Kidwai Memorial Institute of Oncology, Kidwai Memorial Institute of Oncology, Hombegowda nagar, Dr. MH Marigowda road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8288946339 |
| Fax |
|
| Email |
docrn1498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha H S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 105, Operation theater complex, Kidwai Memorial Institute of Oncology, Kidwai Memorial Institute of Oncology, Hombegowda nagar, Dr. MH Marigowda road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448514758 |
| Fax |
|
| Email |
drmamathah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamatha H S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room 105, Operation theater complex, Kidwai Memorial Institute of Oncology, Kidwai Memorial Institute of Oncology, Hombegowda nagar, Dr. MH Marigowda road, Bengaluru
KARNATAKA
560029
India |
| Phone |
9448514758 |
| Fax |
|
| Email |
drmamathah@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Dr M H Marigowda road, Bengaluru, India- 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Nataraj Upadhyay |
| Address |
Room 105, Operation theater complex, Kidwai Memorial Institute of Oncology, Hombegowda nagar, Dr. M H Marigowda road, Bengaluru, India - 560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nataraj Upadhyay |
Kidwai memorial institute of oncology |
Department of Anaesthesiology and Pain Relief, major OT Complex, Kidwai memorial institute of oncology, Dr M H Marigowda Road, Bangalore 560029
Bangalore
KARNATAKA |
8288946339
docrn1498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical 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 |
| Comparator Agent |
Desflurane |
initially 1.3 times the minimum alveolar concentration (MAC) value at high flows of 6L/min till equilibriation point is achieved followed by reducing the dial concentration to achieve age specific MAC of 1 |
| Intervention |
Low flow anesthesia |
Switch over from initial high flow to low flow anesthesia in breast cancer surgeries |
| Comparator Agent |
Sevoflurane |
initially 1.3 times the minimum alveolar concentration (MAC) value at high flows of 6L/min till equilibriation point is achieved followed by reducing the dial concentration to achieve age specific MAC of 1 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20 and 60 years
Willing to informed consent
Belonging to ASA 1 and ASA 2
Body Mass Index (BMI) between 18.5 and 25 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient not willing to give consent
Belonging to ASA 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare equilibration point of Sevoflurane and Desflurane as a switch over point to low flow anesthesia |
within the time period of the surgery intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Arterial blood gas variation due to low flow anesthesia |
1. immediately after changeover to low flow anesthesia
2. 20 minutes after low flow anesthesia
3. immediate post operative |
| Hemodynamic parameters |
every 5 minutes for first 15 minutes, every 10 minutes for next half hour & 15 minutes till end of the surgery |
| Washout time of inhalational agent |
after the last suture till the patient responds & follows the verbal commands |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study is a randomised prospective comparative study between two inhalational agents and switchover to inhalational agents Preoxygenation will be done for 3 minutes with 100% oxygen at 10 litre/min. Inj. Midazolam 0.02mg/kg and Inj. Fentanyl 1mcg/kg will be given as premedications. Patient will be induced with Inj. Propofol 2 mg/kg iv. After adequacy of mask ventilation is checked, Inj. Vecuronium 0.1 mg/kg iv will be administered.
Patient will be intubated with a cuffed endotracheal tube of appropriate size and tube position will be confirmed by End Tidal CO2 (EtCO2) waveform and bilateral equal air entry confirmed by auscultation, secured and connected to the ventilator.
Ventilation will be started at FiO2 of 40-50%, with tidal volume of 7ml/kg body weight on Volume Control (VC) mode, a high fresh gas flow of 6 lts/min (in ratio 40:60, O2:N2O) with dial concentration of 1.3 times the age specific MAC with either Sevoflurane (Group A)or Desflurane (Group B) will be set. The inspired (Fi) and expired (Fe) gas concentration will be noted till a ratio of 0.8 is achieved (equilibration point).
Once the set ratio is achieved, the flow will be reduced to 750ml. Arterial blood gases and time will be noted down. Dial concentration of anesthetic agent will noted and will be changed if needed to maintain age specific MAC of 1. Patient will be maintained on Inj Vecuronium 0.025mg/kg iv. Inj Fentanyl 0.5mcg/kg iv will be given as and when need for analgesia arises.In case inspired O2 concentration fall < 40%, it will be corrected by increasing FiO2 to 55-60%. Hemodynamic parameters like Systolic BP (SBP), Diastolic BP (DBP), Heart rate (HR) , SpO2, inspired (Fi) and expired (Fe) gas concentration of O2, N2O, Sevoflurane/ Desflurane, mean time to achieve equilibration time of the volatile agent will be monitored for every minute for the first 5 minutes followed by every 5 minutes for 30 mins and there on every 15 minutes till the time of extubation.
At the end of surgery (at the time of the completion of the last stitch) N2O and inhalational agent will be switched off. Once the reversal criteria is obtained Inj Neostigmine 0.05mg/kg iv and Inj Glycopyrrolate 0.01mg/kg iv will be given.
When extubation criteria is met patient will be extubated. Recovery time will be noted as time from discontinuation of inhalation agent to the time patient can follow verbal commands. Any critical events of occurred will be noted down and tackled. Patients will be monitored in PACU for 3 hours post-operatively.
|