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CTRI Number  CTRI/2024/12/078701 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 22/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   COMPARATIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Effect of Spinal Anesthesia given in fractions on Hemodynamic stability in patients undergoing prostate surgery  
Scientific Title of Study   Effect of Hyperbaric Bupivacaine as bolus or fractionated dose in sixty and ninety seconds on hemodynamic stability in patients undergoing Transurethral Resection of Prostate under Subarachnoid Block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gloria John 
Designation  Junior Resident  
Affiliation  Govt Medical College Kozhikode 
Address  Department of Anesthesiology Govt Medical College,Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9497051739  
Fax    
Email  gloriatheresajohn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shafna K T  
Designation  Assistant Professor  
Affiliation  GOVT MEDICAL COLLEGE KOZHIKODE  
Address  DEPARTMENT OF ANESTHESIOLOGY GOVERNMENT MEDICAL COLLEGE KOZHIKODE

Kozhikode
KERALA
673008
India 
Phone  8506911421  
Fax    
Email  shafnak87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gloria John 
Designation  Junior Resident  
Affiliation  GOVT MEDICAL COLLEGE KOZHIKODE  
Address  DEPARTMENT OF ANESTHESIOLOGY GOVERNMENT MEDICAL COLLEGE KOZHIKODE

Kozhikode
KERALA
673008
India 
Phone  9497051739  
Fax    
Email  gloriatheresajohn@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology Government Medical College Kozhikode  
 
Primary Sponsor  
Name  Department of Anesthesiology  
Address  Department OF Anesthesiology Govt Medical College Kozhikode  
Type of Sponsor  Government medical college 
 
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 
Gloria John   Government Medical College Kozhikode  Urology Operation Theatre ,Government Medical College Kozhikode
Kozhikode
KERALA 		 9497051739

gloriatheresajohn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (2) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA I AND ASA II

PATIENTS UNDERGOING ELECTIVE TURP SURGERY 
 
ExclusionCriteria 
Details  LOCALISED INFECTION
ALLERGY TO ANESTHETIC DRUGS
INCREASED INTRACRANIAL PRESSURE
PRESENCE OF SPINAL DEFORMITY
HISTORY OF COAGULOPATHY
UNKNOWN DURATION OF SURGERY  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HEMODYNAMIC STABILITY IN TERMS OF HEART RATE ,SYSTOLIC BP,DIASTOLIC BP,MEAN ARTERIAL PRESSURE  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
SENSORY MOTOR BLOCK DURATION,HIGHEST LEVEL OF SENSORY BLOCK,PERCENTAGE DECREASE IN HEART RATE,SYSTOLIC BP,MEAN ARTERIAL PRESSURE,PERFUSION INDEX  1 YEAR 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   01/02/2025 
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="0"
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2037?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   EFFECT OF HYPERBARIC BUPIVCAINE AS BOLUS OR FRACTIONATED DOSE IN SIXTY AND NINETY SECONDS ON HEMODYNAMIC STABILITY  IN TURP SURGERY UNDER SUBARACHNOID BLOCK.HEART RATE,SYSTOLIC BLOOD PRESSURE,DIASTOLIC BLOOD PRESSURE,MEAN ARTERIAL PRESSURE.COMPARE SESORY AND MOTOR BLOCKDURATION,HIGHEST LEVEL OF SENSORY BLOCK,PERCENTAGE DECREASE IN HEART RATE,SYSTOLIC BP MEAN ARTERIAL PRESSURE. 
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