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CTRI Number  CTRI/2024/06/069059 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational, Retrospective study 
Study Design  Other 
Public Title of Study   Anaesthesia In Old Patients Undergoing Hip Fracture Surgery 
Scientific Title of Study   Anaesthesia In Geriatric Patients Undergoing Hip Fracture Surgery: An observational retrospective 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  Dr Minal Harde 
Designation  Professor 
Affiliation  Topiwala National Medical College 
Address  Department of anaesthesia, TNMC Nair Hospital Mumbai Central
Mumbai Central
Mumbai
MAHARASHTRA
400008
India 
Phone  02223027137  
Fax    
Email  minalharde@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Minal Harde 
Designation  Professor 
Affiliation  Topiwala National Medical College 
Address  Department of Anesthesia, TNMC Nair Hospital Mumbai Central
Mumbai Central
Mumbai
MAHARASHTRA
400008
India 
Phone  02223027137  
Fax    
Email  minalharde@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Minal Harde 
Designation  Professor 
Affiliation  Topiwala National Medical College 
Address  Department of anesthesia, Nair Hospital Mumbai Central
Mumbai Central
Mumbai
MAHARASHTRA
400008
India 
Phone  02223027137  
Fax    
Email  minalharde@yahoo.co.in  
 
Source of Monetary or Material Support  
Topiwala National medical college, Nair Hospital, Mumbai 400008, India  
 
Primary Sponsor  
Name  TNMC and Nair Hospital 
Address  TNMC, Nair hospital, mumbai India 400008 
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 
Dr Minal harde  Topiwala National Medical College and BYL Nair Hospital  Department of anesthesia, 5th floor OT Complex, TNMC, Nair Hospital Mumbai 400008
Mumbai
MAHARASHTRA 
02223027137

minalharde@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Project, PG academic committee, TN medical college, BYL Nair Hospital, e,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  92.00 Year(s)
Gender  Both 
Details  Geriatric patients undergoing hip fracture surgery under various anesthesia during the study period.
Patients above 60 years with hip fracture undergoing surgery under anesthesia will be included. 
 
ExclusionCriteria 
Details  Patients with Hip fractures admitted but not operated under any anesthesia will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In geriatric hip fracture surgery following primary outcomes will be noted. Surgical procedure, Duration of surgery, American Society of Anesthesiologists Physical Status Classification scores (ASA scores), Anaesthesia technique used, comparison of various techniques with respect to intraoperative course of patients  Intraoperative and postoperative periods, 
 
Secondary Outcome  
Outcome  TimePoints 
Any perioperative complication
details of anesthesia and
outcome of patients
 
Intra-operative & postoperative till ten days 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   25/07/2024 
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 - NO
Brief Summary  

Hip fracture in elderly is a global public health problem with an increasing incidence due to increasing life expectancy. [1, 2] Hip fracture surgeries are one of the most common emergency orthopaedic procedures performed and the commonest reason for elderly to require an emergency surgery. [3] These patients are a high- risk category of patients for anaesthesia due to advanced age, multiple comorbidities, high perioperative complications [3-5] They are challenging task for anaesthesiologist and are associated with high morbidity and mortality. Hence, we aimed to appraise anaesthesia techniques used in geriatric patients undergoing hip fracture surgery with an objective to compare various techniques with respect to hemodynamic parameters, perioperative course, complications and postoperative outcome of patients.

An observational retrospective study

Total 126 elderly patients underwent hip surgery in 1 year study period. Hence sample size is 126 patients.

All the retrospective data collection will be done from the recorded pre- anesthesia check-up forms, intraoperative and post-operative anaesthesia records and charts of patients who underwent hip fracture repair surgeries under anaesthesia during the study period. Anaesthesia record sheet has all comprehensive perioperative details and are part of patient’s medical record file. 

Detailed evaluation of patients during  Intra-operative and postoperative course will be done. Appropriate statistical tests will be used for data analysis.


 
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