| CTRI Number |
CTRI/2024/11/076882 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of methyl prednisolone on post op recovery in retrograde intra renal surgery |
|
Scientific Title of Study
|
Effectiveness of methylprednisolone on post operative recovery after retrograde intrarenal surgery (rirs)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guntesh kaur |
| Designation |
1st year pg resident of anesthesiology |
| Affiliation |
|
| Address |
Adesh Institute of medical science and research
Bathinda
PUNJAB
151004
India |
| Phone |
8360922492 |
| Fax |
|
| Email |
gunteshkaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Upinder Kaur |
| Designation |
Professor in dept of anesthesiology |
| Affiliation |
|
| Address |
Department of anesthesiology and intestive care adesh intitute of medical science and research (aimsr) , bathinda
Bathinda
PUNJAB
151004
India |
| Phone |
9815033776 |
| Fax |
|
| Email |
upindermander01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Guntesh kaur |
| Designation |
1st year pg resident of anesthesiology |
| Affiliation |
|
| Address |
Adesh institute of medical sciences and research, Adesh university
Bathinda
PUNJAB
151004
India |
| Phone |
8360922492 |
| Fax |
|
| Email |
gunteshkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh institute of medical sciences and research, Adesh university
|
|
|
Primary Sponsor
|
| Name |
Adesh institute of medical sciences and research Adesh university |
| Address |
Adesh institute of medical sciences and research Adesh university
|
| 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 |
| Guntesh kaur |
Adesh institute of medical sciences and research Adesh university |
Operation theatre complex
Department of anesthesiology and intensive care
Bathinda
PUNJAB |
8360922492
gunteshkaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE ADESH UNIVERSITY |
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 |
Effectivenessof Methyl Prednisolone on Post Operative Recovery after Retrograde Intrarenal Surgery (RIRS) |
Methylprednisolone is known for its potent anti-inflammatory properties and has shown promise in mitigating complications associated with surgery-induced ischemia and postoperative pain and nausea vomiting. This study aims to contribute to the existing literature by examining the effects of preoperative single-dose methylprednisolone on quality of recovery of patients undergoing RIRS by utilizing the Quality of Recovery Score (QoR-40).
|
| Comparator Agent |
Effectivenessof Methyl Prednisolone on Post Operative Recovery after Retrograde Intrarenal Surgery (RIRS) |
Methylprednisolone is known for its potent anti-inflammatory properties and has shown promise in mitigating complications associated with surgery-induced ischemia and postoperative pain and nausea vomiting. This study aims to contribute to the existing literature by examining the effects of preoperative single-dose methylprednisolone on quality of recovery of patients undergoing RIRS by utilizing the Quality of Recovery Score (QoR-40). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients of 18-60 years of age of both gender ASA I and ASA II scheduled for elective surgery requiring general anaesthesia.
2. Patient who have solitary kidney stone 10-20mm in size
|
|
| ExclusionCriteria |
| Details |
1. Non consenting patient
2. Diabetic patient
3. Patients who have multiple or bilateral stones, stone diameters less than 10 and more than 20 mm, urethral stones
4. Pregnant patient
5. patient with a history of urological stone surgery in the previous 6 month
6. patient with nephrostomy catheter or Double-J stent
7. A history of urinary tract infection in the last 1 month
8. Patient with any neurological disease and taking any neuropsychiatric medication
9. Patient already on steroids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO study the effect of methyl prednisolone on quality of recovery score |
Baseline(To)
10 min after (T1 )
20 min(T2)
30 min(T3)
40min(T4)
50 min(T5)
60 min(T6)
70 min (T7)
90 min (T90)
100 min (T10)
110 min (T11)
120 min (T12)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative quality of recovery score
2. Time for the first rescue analgesia in recovery room
3. Time for the first rescue antiemetic
4. Total analgesic consumption during the hospital stay (inj ketorolac / inj paracetamol)
5. Total antiemetic consumption (inj ondansetron)
6. To observe any side effects (Hyper glycemia , fever , any other ) |
Baseline(To)
10 min after (T1 )
20 min(T2)
30 min(T3)
40min(T4)
50 min(T5)
60 min(T6)
70 min (T7)
90 min (T90)
100 min (T10)
110 min (T11)
120 min (T12)
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to contribute to the existing literature by examining the effects of preoperative single-dose methylprednisolone on quality of recovery of patients undergoing RIRS. By utilizing the Quality of Recovery Score (QoR-40), a meticulously designed patient-rated questionnaire, we aim to thoroughly assess various aspects of recovery, including pain perception, psychological well-being, physical autonomy, emotional resilience, and physical comfort. Through this research, we strive to provide valuable insights aimed at optimizing postoperative outcomes. |