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CTRI Number  CTRI/2025/09/095453 [Registered on: 29/09/2025] Trial Registered Prospectively
Last Modified On: 27/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study on Hypotension in Unilateral vs. Bilateral Spinal Anaesthesia for PCNL Patients 
Scientific Title of Study   : Comparative evaluation of incidence of hypotension in unilateral versus bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy. 
Trial Acronym  no 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Yadav 
Designation  Post Graduate Student department of Anaesthesiology 
Affiliation  ESIC Medical College and Hos[pital ,Faridabad 
Address  Department of Anaesthesiology ,OT Complex ,3rd floor ,ESIC Medical College and Hospital Faridabad(121001) ,Haryana

Faridabad
HARYANA
121001
India 
Phone  6360203961  
Fax    
Email  manishayadav14057@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anoop Raj Gogia 
Designation  Professor 
Affiliation  ESIC Medical College and Hos[pital ,Faridabad 
Address  Department of Anaesthesiology ,OT Complex ,3rd floor ,ESIC Medical College and Hospital Faridabad(121001) ,Haryana

Faridabad
HARYANA
121001
India 
Phone  09810318291  
Fax    
Email  gogiaanoop@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anoop Raj Gogia 
Designation  Professor 
Affiliation  ESIC Medical College and Hos[pital ,Faridabad 
Address  Department of Anaesthesiology ,OT Complex ,3rd floor ,ESIC Medical College and Hospital Faridabad(121001) ,Haryana

Faridabad
HARYANA
121001
India 
Phone  09810318291  
Fax    
Email  gogiaanoop@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital ,Faridabad 
 
Primary Sponsor  
Name  Manisha Yadav 
Address  Department of Anaesthesiology ,OT Complex ,3rd floor ,ESIC Medical College and Hospital Faridabad(121001) ,Haryana 
Type of Sponsor  Other [Dr Manisha Yadav] 
 
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 Manisha Yadav  ESIC MCH Faridabad  Department of Anaesthesiology,OT Complex,3rd floor,ESIC Medical College and Hos[pital ,Faridabad(121001),Haryana,India
Faridabad
HARYANA 		 06360203961

manishayadav14057@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,,ESIC Faridabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Spinal Anaesthesia  • Group B (Bilateral spinal anaesthesia 15- 20 min) in this group patients will be given 2.5 ml hyperbaric bupivacaine (0.5%) with fentanyl 10mcg at the level of L2-3 intervertebral space.  
Intervention  SPINAL ANAESTHESIA  •Group U (Unilateral spinal anaesthesia 15-20 MIN) in this group patients will be given 2.5 ml hyperbaric bupivacaine (0.5%) with fentanyl 10mcg at level of L2-3 intervertebral space. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients of Age 18-60 years with American Society of Anaesthesiologist physical status I and II of either sex posted for elective percutaneous nephrolithotomy. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the incidence of hypotension following unilateral spinal and bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.  Baseline
2 min
4 min
6 min
8 min
10 min
12 min
14 min
16 min
18 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
55 min
60 min

 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare in both groups
• the incidence of bradycardia
• spinal block characteristics
-Sensory(onset, level and duration)
-Motor(onset, level and duration)
• total dose of mephentermine required
•duration of analgesia
 		 Baseline
2 min
4 min
6 min
8 min
10 min
12 min
14 min
16 min
18 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
55 min
60 min

 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/10/2025 
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  

Study Title:

Comparative evaluation of efficacy of unilateral versus bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.

Study Design:

  • Type Randomized controlled trial

  • Location ESIC Medical College and Hospital, Faridabad, Haryana

  • Duration October 2025 to March 2027

Participants:

  • Inclusion

    • Adults aged 18–60 years

    • ASA physical status I or II

    • Scheduled for elective percutaneous nephrolithotomy

  • Exclusion

    • Contraindications to spinal anaesthesia (e.g., coagulation disorders, infection, allergy, increased intracranial pressure)

    • Pregnant/lactating females

    • BMI > 30 kg/m²

    • Expected surgery duration > 2 hours

Sample Size

  • Total of 80 patients

Group Allocation

  • Group U Unilateral spinal anaesthesia (n=40)

  • Group B Bilateral spinal anaesthesia (n=40)

Objectives

  • Primary Objective

    • Compare incidence of hypotension between the two groups

  • Secondary Objectives

    • Incidence of bradycardia

    • Spinal block characteristics:

      • Sensory onset, level, duration

      • Motor onset, level, duration

    • Total dose of mephentermine required

    • Duration of anaesthesia

Assessment & Analysis

  • Data will be compiled and analyzed statistically to evaluate outcomes.

 
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