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
|
|
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
|
|
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. |