| CTRI Number |
CTRI/2025/12/099641 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative study between two drugs which will be used as an adjuvent in spinal anaesthetic drug for patients undergoing a kidney stone removal surgery. |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and fentanyl as an adjuvent to 0.5 % isobaric levobupivacaine in thoracic segmental spinal anaesthesia for patients undergoing Percutaeneous Nephrolithotomy. |
| 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 Swapnali Sarjerao Suryawanshi |
| Designation |
Anaesthesiologist |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Second floor, Parul Sevashram Hospital, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8780981816 |
| Fax |
|
| Email |
sapusurya07618@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnali Sarjerao Suryawanshi |
| Designation |
Anaesthesiologist |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Second floor, Parul Sevashram Hospital, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8780981816 |
| Fax |
|
| Email |
sapusurya07618@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnali Sarjerao Suryawanshi |
| Designation |
Anaesthesiologist |
| Affiliation |
Parul Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Second floor, Parul Sevashram Hospital, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8780981816 |
| Fax |
|
| Email |
sapusurya07618@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia, Vadodara, Gujarat, 391760, India |
|
|
Primary Sponsor
|
| Name |
Dr Swapnali Sarjerao Suryawanshi |
| Address |
Department of Anaesthesia, Second floor, Parul Sevashram Hospital, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia, Vadodara, Gujarat, 391760, India |
| 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 |
| Dr Swapnali Sarjerao Suryawanshi |
Parul Sevashram Hospital |
Department of Anaesthesia, Second floor, Parul Institute of Medical Sciences and Research, Parul University, Limda, Waghodia ,Vadodara, 391760
Vadodara
GUJARAT |
08780981816
sapusurya07618@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research (PU-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to sign informed consent for undergoing elective thoracic segmental spinal anaesthesia
2)Patients above 18 years and below 60 years of age
3)Patients belonging to American Society of Anaesthesiologists physical status I, II and III |
|
| ExclusionCriteria |
| Details |
1)Patients contraindicated for spinal anaesthesia
2)Patients with known allergy, sensitivity or any other form of reaction to the study drug
3)Pregnant or lactating patients or patients presenting for emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of addition of two adjuvent drugs Dexmedetomidine and Fentanyl in Isobaric Levobupivacaine in thoracic segmental spinal anaesthesia in patients undergoing Percutaeneous Nephrolithotomy on haemodynamic parameters, onset and duration of motor and sensory block, duration of analgesia and perioperative complications |
To note the effect every 5 minutes for first 15 minutes then every 30 minutes till the end of surgery for next 5 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/12/2025 |
| 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="0"
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 is an observational cross sectional study comparing the effect of addition of two adjuvant drugs Dexmedetomidine and Fentanyl in Isobaric Levobupivacaine in thoracic segmental spinal anaesthesia in patients undergoing Percutaeneous Nephrolithotomy on following parameters 1)Haemodynamics 2)Onset of motor and sensory block 3)Duration of motor and sensory block 5) Perioperative complications Study is to be conducted on 50 patients divided into 2 groups of 25 each. |