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CTRI Number  CTRI/2023/06/054166 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare recovery pattern in two different types of anesthesia: one involving propofol medication given through a special equipment that controls the dosage rate, and the other using sevoflurane gas anesthesia, for patients undergoing surgery for kidney stones (retrograde intrarenal surgery) 
Scientific Title of Study   Comparison of recovery profile between target controlled infusion of propofol & sevoflurane anaesthesia in patients undergoing retrograde intrarenal surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Veena S Choudannanavar  
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College  
Address  Department of Anaesthesiology,
MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  8123357832  
Fax    
Email  veenasc97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetha C R 
Designation  Professor and Head 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology,
MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha C R 
Designation  Professor and Head 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology,
MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College, Bangalore  
 
Primary Sponsor  
Name  MS Ramaiah Medical College  
Address  New BEL Road, MSRIT Post, Bangalore, 560054 
Type of Sponsor  Private 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 
Dr Geetha CR   MS Ramaiah Medical College and Hospital   Department of Anaesthesiology, Second floor, MS Ramaiah Medical College, New BEL Road, Bangalore 560054
Bangalore
KARNATAKA 
9900482828

jageedha@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N209||Urinary calculus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sevoflurane anaesthesia   Anaesthesia with inhalational agent-Sevoflurane 
Intervention  Target controlled infusion of Propofol  Anaesthesia with Target controlled infusion of Propofol  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 20-65 years
Patients undergoing elective retrograde intrarenal surgery (RIRS)
 
 
ExclusionCriteria 
Details  Patients with severe cardiovascular, renal, hepatic disorder
Patients with neuropsychiatric disorders
Patients with hemodynamic instability
Patients with drug allergy
Patients with history of malignant hyperthermia
Patients with muscular dystrophy
Patients with electrolyte imbalance
Conversion of procedure to Percutaneous nephrolithotripsy(PCNL) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Recovery time and extubation time assessment   Recovery time is the interval from cessation of anaesthetic agents to eye opening in response to verbal command.
Extubation time is the time interval from the end of surgery to removal of endotracheal tube  
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic profile, Modified observers assessment of alertness/sedation scale score, discharge time assessment   Hemodynamic profile will be noted pre-anaesthesia, pre induction, when BIS value reaches 40-60, at intubation, & at 10 minute intervals till extubation.
Modified observers assessment of alertness/sedation scale score will be assessed every 15 minutes from arrival of the patient at the post anaesthesia care unit till discharge.
Discharge time is the time interval between patient’s arrival to post anaesthesia care unit (PACU) until the modified Aldrete score reaches ≥9 points 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   30/06/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Rapid recovery is a highly desirable objective of anaesthesia. Extended recovery time from general anaesthesia may lead to severe complications like hypoxemia, hypercarbia, hypoventilation, etc. Recovery time is influenced by patient factors, anaesthetic agents used, and surgical factors.

Inhalational anaesthesia is the most popular form of anaesthesia used since it is easy to administer and can be rapidly titrated. But these anaesthetic gases used pose a threat as they are potent greenhouse gases that can contaminate the air and contribute to the greenhouse effect. The sole modality that completely eliminates the use of anaesthetic gases is total intravenous anaesthesia (TIVA). 

The increased popularity of TIVA can be attributed to pharmacokinetics and pharmacodynamics of short acting drugs like propofol and remifentanil. Propofol can be administered through target controlled infusion (TCI) with precise concentration using Marsh or Schnider pharmacokinetic models. TCI involves automated intravenous drug administration that regulates drug delivery rates to achieve desired target plasma concentration (Cp) or at effect site concentration (Ce). TCI offers several advantages over conventional inhalational anaesthesia, including better post operative recovery, stable hemodynamics, a reduced rate of post-operative nausea and vomiting.

Hence, the current study is designed to compare two standard techniques of anaesthesia, that is, ‘TIVA via TCI’ and ‘inhalational anaesthesia’, while maintaining bispectral index (BIS) value between 40-60, in patients undergoing retrograde intrarenal surgery (RIRS). 

This study is a randomised controlled trial with a sample size of 100 and will be conducted in MS Ramaiah Medical College, Bangalore. The primary outcome will be to compare recovery time and extubation time in the two groups. The secondary outcome will be to compare hemodynamic profile, Modified observer’s assessment of alertness/sedation scale score and discharge time in the two groups. 
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