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CTRI Number  CTRI/2025/11/098045 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 25/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparing Urination Problems After Surgery in Diabetic Patients Receiving Different Types of Anesthesia. 
Scientific Title of Study   Comparative Evaluation of Postoperative Urinary Retention in Diabetic Patients Undergoing Surgery with General Versus Spinal Anesthesia: An Observational Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pandi TM 
Designation  Pg scholar 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203 India.

Chennai
TAMIL NADU
603203
India 
Phone  06385766568  
Fax    
Email  pandiagri55@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujina Hermin  
Designation  Assistant Professor 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4-26,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203 India

Chennai
TAMIL NADU
603203
India 
Phone  9944567803  
Fax    
Email  sujinaa@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Pandi TM 
Designation  Pg scholar 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203 India.

Chennai
TAMIL NADU
603203
India 
Phone  06385766568  
Fax    
Email  pandiagri55@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology 
SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India. 
 
Primary Sponsor  
Name  SRM Institute of Science and Technology 
Address  SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India. 
Type of Sponsor  Research institution and hospital 
 
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 Sujina Hermin  SRM Medical College and Hospital  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu 603203 India.
Chennai
TAMIL NADU 		 9944567803

sujinaa@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E082||Diabetes mellitus due to underlying condition with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients aged above 18 years
2.ASA physical status I, II, and III
3.Diagnosed with diabetes mellitus (Type 1 or Type 2)
4.Both male and female genders
5.Undergoing elective surgeries under general or spinal anesthesia 
 
ExclusionCriteria 
Details  1.Pre-existing urogenital pathologies
2.Patients with indwelling urinary catheters prior to surgery
3.Patients requiring postoperative mechanical ventilation
4.Intraoperative blood loss greater than or equal to 200 ml (can contribute to hemodynamic instability and affect bladder function)
5.History of neurological diseases affecting bladder function
6.Use of medications affecting bladder function
7.Emergency surgeries or surgeries lasting excessively long
8.Patients with chronic kidney disease stage 3 or higher (may influence urinary function)
9.Patients unable to provide informed consent or with cognitive impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine how often urine retention occurs after surgery in diabetic patients receiving general versus spinal anesthesia.  Assessments will be performed at 2 hours, 4 hours, and 6 hours postoperatively, and will continue until the patient passes urine spontaneously 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   24/12/2025 
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="5"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pandiagri55@gmail.com].

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will evaluate postoperative urinary retention (POUR) in diabetic patients undergoing elective surgery under general or spinal anesthesia. A total of 132 patients will be included, and preoperative details, intraoperative fluids, urine output, and surgery duration will be recorded. After surgery, patients will be monitored for urinary retention, and the time to first spontaneous urination will be noted. If urination is delayed beyond 6 hours, a bladder scan will be done. The study aims to identify the safer anesthesia technique and factors contributing to POUR in diabetic patients. 
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