| 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
|
|
|
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
|
|
|
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.
|