CTRI Number |
CTRI/2025/05/086086 [Registered on: 01/05/2025] Trial Registered Prospectively |
Last Modified On: |
01/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Understanding Recovery: Two Types of Anaesthesia Used in Breast Lump Removal
|
Scientific Title of Study
|
Recovery characteristics after propofol based induction and maintenance of anaesthesia and sevoflurane based induction and maintenance anaesthesia in case of breast Lump Excision
|
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.Vignesh M.J. |
Designation |
Post graduate |
Affiliation |
Institute of Anaesthesiology,Madurai Medical College |
Address |
Room No. 249, Institute of Anaesthesiology, Government Rajaji Hospital, Madurai Medical College, Alwarpuram, Madurai.
Madurai TAMIL NADU 625020 India |
Phone |
9489029414 |
Fax |
|
Email |
vignesh.jayaprakash94@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. N. Rajanalini, M.D., D.G.O. |
Designation |
Professor |
Affiliation |
Institute of Anaesthesiology, Madurai Medical College. |
Address |
Room No. 249, Institute of Anaesthesiology, Government Rajaji Hospital, Madurai Medical College, Alwarpuram, Madurai.
Madurai TAMIL NADU 625020 India |
Phone |
8056057566 |
Fax |
|
Email |
rajanalinimmc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr.Vignesh M.J. |
Designation |
Post graduate |
Affiliation |
Institute of Anaesthesiology, Madurai Medical College. |
Address |
Room No. 249, Institute of Anaesthesiology, Government Rajaji Hospital, Madurai Medical College, Alwarpuram, Madurai.
Madurai TAMIL NADU 625020 India |
Phone |
9489029414 |
Fax |
|
Email |
vignesh.jayaprakash94@gmail.com |
|
Source of Monetary or Material Support
|
Government Rajaji Hospital, Madurai Medical College, Madurai. |
|
Primary Sponsor
|
Name |
Government Rajaji Hospital Madurai Medical College |
Address |
Administration Block, Government Rajaji Hospital,
Madurai Medical College Campus,
Alwarpuram, Madurai |
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 |
DRVIGNESHMJ |
Government Rajaji Hospital |
MOT 2 and MOT 3, Fourth Floor,
JICA Building,
Institute of Anaesthesiology,
Government Rajaji Hospital and Madurai Medical College,
Madurai, Tamil Nadu. Madurai TAMIL NADU |
9489029414
vignesh.jayaprakash94@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,Madurai Medical College, Government Rajaji Hospital, Madurai. |
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 |
Group propofol patients induced and maintained with propofol |
Group Propofol patients were induced with 2mgkg propofol intravenously followed by infusion of 12mgkghr for 10mins10mgkghr for 20 mins and 8mgkghr till end of procedure |
Comparator Agent |
Sevoflurane patient induced and maintained with sevoflurane |
Group Sevoflurane patients were induced with 8 sevoflurane in 4Lmin nitrous oxide and 2Lmin oxygen mixture and maintained with 3.5 sevoflurane with spontaneous breathing |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
ASA 1 and ASA 2 Patient , those who are willing to give informed written consent. |
|
ExclusionCriteria |
Details |
1.Patient on sedative or opioid medications
2.Psychiatric or neurological disease
3.Susceptible to malignant Hyperthermia
4.Patient with significant cognitive impairment
5.Airway MPG 3 and 4
6.Lack of consent |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Time from end of procedure to 1.first spontaneous movement, 2.spontaneous eye
opening
3.removal of LMA
4.Followed verbal commands 5.Became fully oriented to
time and place |
Outcome assessments will be conducted at baseline pre-anaesthesia, intraoperative period, immediate postoperative period 30 min, 1 hr, 2 hrs, short-term recovery 4 hrs, 8 hrs, and on postoperative day 1 24 hrs after surgery.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Time to achieve Aldrete score more than 9 phase 1 recovery
2.Time to achieve PADSS score more than 9 Phase 2 recovery |
1.For Aldrete score every 5 minutes postoperatively until score more than 9
2.For PADSS score at 30, 60, 90 minutes, & then hourly until score more than 9 |
|
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)
|
12/05/2025 |
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 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
|
A surgical procedure performed on a patient admitted and discharged on the same day of surgery is an accepted practice to make hospital resources available for a greater number of patients as each patient gets discharged earlier from the hospital Rapid induction and recovery may lead to faster operating room turnover shorter recovery room stay and earlier discharge to home
Propofol has low lipid solubility and it gets eliminated rapidly from circulation Propofol is proven intravenous anaesthetic agent for day care procedures due to rapid onset of action with early recovery less incidence of post operative nausea and vomiting Sevoflurane is non inflammable highly fluorinated anaesthetic agent with pleasant smell It is potent hypnotic and fairly non irritant to the upper airway Sevoflurane has low blood gas co- efficient and produces characteristics of fast induction and rapid emergence from anaesthesia Inhalational induction using sevoflurane is rapid smooth and well tolerated in both children and adults
Propofol based anaesthesia is associated with hypotension, bradycardia pain on injection and may have allergic reaction Sevoflurane based anaesthesia provides relatively stable hemodynamics Many studies have been done for phase I recovery but not much work done on phase II recovery with respect to ready for discharge home criteria So we conducted this study to compare recovery profile in both groups Our primary goal was to assess and compare phase I - early recovery time to achieve Aldrete score more than 9 in recovery room as well as phase 2 discharge to home recovery time to achieve PADSS score more than 9 in both the groups Our secondary goal was to assess and compare induction quality in terms of LMA insertion conditions in both the groups |