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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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