| CTRI Number |
CTRI/2025/04/085424 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of effectivness of being completely unconscious and only losing sensation at operative area in patients undergoing kidney stone removal surgery |
|
Scientific Title of Study
|
Comparison of efficacy of thoracic segmental spinal anaesthesia versus general anaesthesia in patient undergoing percutaneous nephrolithotomy: a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Azhar Khan |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09340895273 |
| Fax |
|
| Email |
azhar.khan.789042@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mridul Dhar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridul Dhar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care AIIMS Rishikesh Virbhadra Road Rishikesh, Dehradun , uttarakhand 249203 |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
Not available |
| Type of Sponsor |
Other [] |
|
|
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 Mohammad Azhar khan |
Department of Anaesthesiology and critical care level 6 OT complex |
Department of Anaesthesiology and critical care,level 6 ,Aiims Rishikesh, Virbhadra Road Rishikesh, Dehradun 249203
Dehradun
UTTARANCHAL |
09340895273
azhar.khan.789042@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Aiims Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anaesthesia |
Patients will receive general anaesthesia with IV induction agents (Propofol, Etomidate, or Ketamine), Fentanyl, Midazolam, and IV muscle relaxants. They will then be attached to a ventilator with maintenance inhalational anaesthesia using Sevoflurane throughout the surgery. All intraoperative vitals, ventilator settings, intake-output charting, and the total amount of drugs used will be noted. |
| Intervention |
Thoracic segmental spinal anaesthesia |
Patients will receive thoracic spinal anaesthesia in the form of an intrathecal injection with preservative-free isobaric levobupivacaine 0.5% and preservative-free fentanyl, resulting in segmental spinal anaesthesia desired at the T6–T12 level. Additionally, intraoperative vitals, intake-output charting, and the total amounts of drugs used for anaesthesia and analgesia will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist Grade I-III patients with unilateral And single renal stone |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Patients with severe systemic medical illness ASA GRADE IV-V
Patients having BMI more than 40
Patients with local site infections
Patients with known bleeding disorder or coagulopathy
Patients with suspected raised intracranial pressure
Patients having spinal deformities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery following surgery |
Quality of recovery will be assessed using a questionnaire night before surgery and at 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery Time in post anaesthesia care unit (PACU) |
At every 15 minutes intervals after surgery gets over till patient gets discharged from PACU |
| Compare the Length of stay in the hospital |
from the day of surgery till the patient gets discharged |
| compare time to first analgesia in both groups |
In Post operative care unit(PACU) till the patient gets discharged from PACU |
| To compare Post operative nausea and vomiting in both groups |
At every 15 minutes intervals after surgery gets over till patients get discharged from post operative care unit(PACU) |
| To do cost benefit analysis in both groups |
from medical records and bills at the time of discharge
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="6"
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
|
This trial is a randomised open label prospective parallel arm active controlled trial to compare the quality of Recovery at 24 hours following surgery as a primary outcome and to compare the length of stay in hospital in post operative , comparing post operative nausea vomiting in both groups ,cost-benefit analysis ,time to first analgesia as secondary outcomes between General anaesthesia and Thoracic Spinal anaesthesia group of patients undergoing elective percutaneous nephrolithotomy surgery (PCNL) for renal stone disease In AIIMS, Rishikesh in approximately next 18 months from the expected date of first allotment |