FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083216 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of hemodynamics in spinal anaesthesia in lower limb surgeries as bolus dose , as fractionated and combined with epidural blockade. 
Scientific Title of Study   Comparison of hemodynamic stability in patients undergoing lowerlimb surgeries under spinal anaesthesia using hyperbaric bupivacaine as bolus, fractionated or combined with epidural blockade. 
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 FAHMIDA K 
Designation  Junior Resident 
Affiliation  Government medical college, Kozhikode 
Address  Department of Anaesthesiology, Government Medical College, Kozhikode.

Kozhikode
KERALA
673008
India 
Phone  8606474276  
Fax    
Email  fahmidakalody@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. REKHA K 
Designation  Professor (CAP) 
Affiliation  Government medical college, Kozhikode 
Address  Department of Anaesthesiology, Government Medical College, Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9846179497  
Fax    
Email  rekhakrish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr FAHMIDA K 
Designation  Junior Resident 
Affiliation  Government medical college, Kozhikode 
Address  Department of Anaesthesiology , Government Medical College, Kozhikode.

Kozhikode
KERALA
673008
India 
Phone  8606474276  
Fax    
Email  fahmidakalody@gmail.com  
 
Source of Monetary or Material Support  
Government medical college , kozhikode, Kozhikode district Kerala state India 673008 
 
Primary Sponsor  
Name  Dr FAHMIDA K 
Address  Junior Resident, Department of Anaesthesiology, Government Medical College , Kozhikode, Kerala, India, 673008. 
Type of Sponsor  Other [Self] 
 
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 
FAHMIDA K  Government medical college, Kozhikode.   First floor, Orthopaedics Operation Theatre, Major Operation Theatre Complex,
Kozhikode
KERALA 		 8606474276

fahmidakalody@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: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA status 1 or 2
Height 140cm to 170 cm
Those who are undergoing lower limb surgeries 
 
ExclusionCriteria 
Details  Patient refusal
Localised infection at spinal site
Known allergy to anesthetic drugs
Coagulopathies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Heart rate, Blood pressure  At base line 
 
Secondary Outcome  
Outcome  TimePoints 
Level of blockade  At base line 
 
Target Sample Size   Total Sample Size="71"
Sample Size from India="71" 
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)   03/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/04/2025 
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)   Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 [fahmidakalody@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is to compare and assess hemodynamic stability of low dose spinal epidural , spinal bolus and fractionated spinal in lower limb surgeries using hyperbaric bupivacaine. There are three groups in this study and study aims at assessing which group is hemodynamically stable in terms of heart rate, mean arterial pressure and peripheral saturation of oxygen.

 
Close